Difenidramina* e seus sais
ANVISA lists this substance among materials that may not be used in personal-hygiene products, cosmetics or perfumes in Brazil.
Regulatory decision and full conditions
- Status
- Prohibited
- Legal role
- Binding rule
- Regulatory summary
- ANVISA lists this substance among materials that may not be used in personal-hygiene products, cosmetics or perfumes in Brazil.
- Conditions and restrictions
- Difenidramina* e seus sais
Substance identity
- Official source name
- Difenidramina* e seus sais
- CAS
- 58-73-1; 147-24-0; 88637-37-0
- EC
- 200-396-7; 205-687-2; 289-432-0
- Identity mapping
- cas_number
- Linked ingredient
- DIPHENHYDRAMINE HCL
Linked CosIng identity data
Names and aliases
CosIng description: diphenhydramine hydrochloride
EU inventory restriction note: II/339
Recorded cosmetic function: HAIR CONDITIONING, SKIN CONDITIONING
Function pages:HAIR CONDITIONING, SKIN CONDITIONING
View the complete ingredient profileCross-market snapshot for this identity
Exact linked records currently present in this site. An absent market means no imported exact match, not permission to use the substance.
European Union
1 linked record
Open supporting recordGreat Britain
1 linked record
Open supporting recordCanada
1 linked record
Open supporting recordNew Zealand
1 linked record
Open supporting recordASEAN
1 linked record
Open supporting recordChina
1 linked record · 1 with specific conditions
Open supporting recordSouth Korea
1 linked record · 1 with specific conditions
Open supporting recordBrazil
Current record1 linked record · 1 with specific conditions
Open supporting recordIndia
1 linked record · 1 with specific conditions
Open supporting recordSaudi Arabia
1 linked record
Open supporting recordVerified chemistry for CAS 147-24-0
Diphenhydramine Hydrochloride
- IUPAC name
- 2-benzhydryloxy-N,N-dimethylethanamine;hydrochloride
- Molecular formula
- C17H22ClNO
- Molecular weight
- 291.8 g/mol
- Exact mass
- 291.1389920 Da
- Monoisotopic mass
- 291.1389920 Da
- Topological polar surface area
- 12.5 Ų
- Molecular complexity
- 211.0
- Formal charge
- 0
- Hydrogen-bond donors
- 1
- Hydrogen-bond acceptors
- 2
- Rotatable bonds
- 6
- Heavy atoms
- 20
- Covalent units
- 2
Names and synonyms reported to PubChem
16 more reported names
External database identifiers
- ChEMBL:CHEMBL1620
- EPA DTXSID:DTXSID4020537
- PubMed:16266919
- PubMed:1679
Advanced structure statistics
- Defined atom stereocentres
- 0
- Undefined atom stereocentres
- 0
- Defined bond stereocentres
- 0
- Undefined bond stereocentres
- 0
- 3D conformers
- 0
Machine-readable structure identifiers
- SMILES
CN(C)CCOC(C1=CC=CC=C1)C2=CC=CC=C2.Cl- InChI
InChI=1S/C17H21NO.ClH/c1-18(2)13-14-19-17(15-9-5-3-6-10-15)16-11-7-4-8-12-16;/h3-12,17H,13-14H2,1-2H3;1H- InChIKey
PCHPORCSPXIHLZ-UHFFFAOYSA-N
Retrieved from NIH PubChem on 2026-08-31 by checksum-valid CAS matching. Chemical properties do not replace the regulatory decision on this page.
Verified chemistry for CAS 58-73-1
Diphenhydramine
- IUPAC name
- 2-benzhydryloxy-N,N-dimethylethanamine
- Molecular formula
- C17H21NO
- Molecular weight
- 255.35 g/mol
- Exact mass
- 255.162314293 Da
- Monoisotopic mass
- 255.162314293 Da
- XLogP3
- 3.3
- Topological polar surface area
- 12.5 Ų
- Molecular complexity
- 211.0
- Formal charge
- 0
- Hydrogen-bond donors
- 0
- Hydrogen-bond acceptors
- 2
- Rotatable bonds
- 6
- Heavy atoms
- 19
- Covalent units
- 1
Names and synonyms reported to PubChem
16 more reported names
External database identifiers
Advanced structure statistics
- Defined atom stereocentres
- 0
- Undefined atom stereocentres
- 0
- Defined bond stereocentres
- 0
- Undefined bond stereocentres
- 0
- 3D pharmacophore features
- 4
- 3D rings
- 2
- 3D hydrophobes
- 0
- 3D acceptor features
- 1
- 3D donor features
- 0
- 3D anionic centres
- 0
- 3D cationic centres
- 1
- 3D conformers
- 10
- Effective 3D rotors
- 6.0
Machine-readable structure identifiers
- SMILES
CN(C)CCOC(C1=CC=CC=C1)C2=CC=CC=C2- InChI
InChI=1S/C17H21NO/c1-18(2)13-14-19-17(15-9-5-3-6-10-15)16-11-7-4-8-12-16/h3-12,17H,13-14H2,1-2H3- InChIKey
ZZVUWRFHKOJYTH-UHFFFAOYSA-N
Retrieved from NIH PubChem on 2026-08-31 by checksum-valid CAS matching. Chemical properties do not replace the regulatory decision on this page.
Verified chemistry for CAS 88637-37-0
Diphenhydramine Citrate
- IUPAC name
- 2-benzhydryloxy-N,N-dimethylethanamine;2-hydroxypropane-1,2,3-tricarboxylic acid
- Molecular formula
- C23H29NO8
- Molecular weight
- 447.5 g/mol
- Exact mass
- 447.18931688 Da
- Monoisotopic mass
- 447.18931688 Da
- Topological polar surface area
- 145.0 Ų
- Molecular complexity
- 439.0
- Formal charge
- 0
- Hydrogen-bond donors
- 4
- Hydrogen-bond acceptors
- 9
- Rotatable bonds
- 11
- Heavy atoms
- 32
- Covalent units
- 2
Names and synonyms reported to PubChem
16 more reported names
External database identifiers
- ChEMBL:CHEMBL1201089
- EPA DTXSID:DTXSID80237211
Advanced structure statistics
- Defined atom stereocentres
- 0
- Undefined atom stereocentres
- 0
- Defined bond stereocentres
- 0
- Undefined bond stereocentres
- 0
- 3D conformers
- 0
Machine-readable structure identifiers
- SMILES
CN(C)CCOC(C1=CC=CC=C1)C2=CC=CC=C2.C(C(=O)O)C(CC(=O)O)(C(=O)O)O- InChI
InChI=1S/C17H21NO.C6H8O7/c1-18(2)13-14-19-17(15-9-5-3-6-10-15)16-11-7-4-8-12-16;7-3(8)1-6(13,5(11)12)2-4(9)10/h3-12,17H,13-14H2,1-2H3;13H,1-2H2,(H,7,8)(H,9,10)(H,11,12)- InChIKey
SPCKHVPPRJWQRZ-UHFFFAOYSA-N
Retrieved from NIH PubChem on 2026-08-31 by checksum-valid CAS matching. Chemical properties do not replace the regulatory decision on this page.
Official source and provenance
- Registered source
- Brazil ANVISA consolidated prohibited substances — RDC 529/2021 through RDC 1.030/2026
- Source reference
- RDC 529/2021 consolidated annex, entry 339 (through RDC 1.030/2026)
- Source record ID
annex:339- Source version
- RDC 529/2021 consolidated through RDC 1.030/2026
- Source language
- Portuguese with official English identity where published
- Translation status
- Official English translation · English translation
- Effective date
- 2026-06-15
- Source updated
- 2026-06-15
- Snapshot checked
- 2026-08-31 15:26 UTC
- Validation method
- pdfplumber government baseline + 4 RDC 1.030 exclusions + 15 additions; 1,387 substantive rows
- SHA-256
a212e85540a186a842664fbdd4f351af0b1b4baeeb0c4765b9b52c6ce91c1e84
Registered dataset notes
- Dataset coverage
- All 1,387 substantive current prohibited rows after applying RDC 1.030/2026 additions, amendments and exclusions to RDC 529/2021
- Authority note
- Binding consolidated prohibited list for personal-hygiene products, cosmetics and perfumes
How this record fits the market dataset
Status distribution
Condition text is present on 1387 of 1387 current records. An empty condition field is interpreted according to the record type above; it is never converted into an unrestricted-use claim.
Brazil market context
Complete prohibited dataset plus current restricted-list workflow
Coverage version: ANVISA RDC 1.029/2026 and RDC 1.030/2026, published 15 June 2026
All 1,387 substantive current prohibited rows in RDC 529/2021 consolidated through RDC 1.030/2026, plus the current RDC 1.029 restricted-list and identity workflow.
Verification checklist
- Resolve Portuguese, INCI and CAS identity with the ANVISA crosswalk.
- Check the consolidated prohibited list including RDC 1.030/2026 changes.
- Apply RDC 1.029/2026 restrictions and the still-effective complementary rules.
- Verify Mercosur incorporation, regularisation, labelling and transition periods.
Official market sources
- Brazil ANVISA INCI translation panelIdentity and labelling crosswalk only; regulatory lists must be sourced separately
- Brazil ANVISA restricted substances — RDC 1.029/2026Binding ANVISA resolution effective on publication; replaced RDC 530/2021 for this list part
- Brazil ANVISA consolidated prohibited substances — RDC 529/2021 through RDC 1.030/2026Binding consolidated prohibited list for personal-hygiene products, cosmetics and perfumes
Verification workflow and record completeness
Before using this result in a compliance decision
- Confirm that “Difenidramina* e seus sais” and every CAS/EC identifier refer to the material in your supplier specification.
- Resolve Portuguese, INCI and CAS identity with the ANVISA crosswalk.
- Check the consolidated prohibited list including RDC 1.030/2026 changes.
- Apply RDC 1.029/2026 restrictions and the still-effective complementary rules.
- Verify Mercosur incorporation, regularisation, labelling and transition periods.
- Document the source version and recheck the regulator before manufacture, notification or market placement.
Fields available in this record
- Official substance nameAvailable
- CASAvailable
- ECAvailable
- Separate condition textAvailable
- Effective dateAvailable
- Snapshot hash and methodAvailable
Questions this page answers
Stable citation
Difenidramina* e seus sais. RDC 529/2021 consolidated annex, entry 339 (through RDC 1.030/2026). Brazil. Source version RDC 529/2021 consolidated through RDC 1.030/2026. CosIng Checker regulatory record: https://cosingchecker.com/regulations/br/records/13545/
Cite the regulator as the legal authority. This page is a structured evidence index and verification aid, not a substitute for the official text or professional legal assessment.
Interpretation and limits for Brazil
This official record identifies the substance as prohibited for cosmetic use in the stated market scope.
Do not rely on a formulation containing this identity until the cited source, effective date and exact substance match have been verified.
How to interpret the legal role
The cited row forms part of a binding rule or legally incorporated list for this market.
Evidence on this page
- Recorded outcome: Prohibited
- Legal role: Binding rule
- Source version: RDC 529/2021 consolidated through RDC 1.030/2026
- Effective date: 2026-06-15
What it does not prove
RDC 1.030/2026 amends rather than replaces the prohibited baseline, and the second restricted-list revision was still under consultation in July 2026.
Further authoritative substance research
These sources can add identity, safety, exposure or hazard context. A link is not evidence that the database contains this exact substance, and none of these sources overrides the market decision above.
Cosmetic Ingredient Review safety assessments
Expert Panel conclusions, assessed ingredient groups, use conditions, dates and report documents
Independent expert review considered by FDA; not a government approval or binding market rule
Research this identity at the sourceFDA Global Substance Registration System
UNII identifiers, preferred names, substance types, codes and public substance relationships
Identity registry only; UNII availability does not imply FDA review or approval
Research this identity at the sourceILO/WHO International Chemical Safety Cards
Hazards, symptoms, first aid, storage, incompatibilities and physical properties for covered chemicals
International occupational chemical-safety reference; not cosmetic-use approval
Research this identity at the sourceJapan NITE-CHRIP
Chemical identity, Japanese and foreign legal lists, GHS hazards and exposure-related information
Chemical-management evidence; cosmetic status remains governed by the applicable MHLW standard and market rules
Research this identity at the sourceNIOSH Pocket Guide to Chemical Hazards
REL, PEL, IDLH, properties, exposure routes, symptoms, target organs, first aid and measurement methods for covered workplace chemicals
US occupational-health guidance and limits; not a cosmetic ingredient decision
Research this identity at the sourceOECD eChemPortal
Gateway to authority-owned physical-property, fate, ecotoxicity, toxicity, exposure and GHS records
Discovery gateway; each linked authority remains responsible for its data
Research this identity at the sourceUS EPA CompTox CTX APIs
API key required for importDTXSID identity, experimental and predicted properties, toxicity, bioactivity, exposure and environmental data
Scientific and computational evidence; predictions must remain labelled and do not determine cosmetic legality
Research this identity at the source