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Annex II Entry 339 20/10/2010

Diphenhydramine (INN) and its salts

Diphenhydramine (INN) and its salts is listed in Annex II as a prohibited substance for cosmetic products placed on the EU market.

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Prohibited substance— Annex II, EU Regulation 1223/2009
Entry: 339

Chemical identity and properties

PubChem 2D chemical structure for CAS 147-24-0
CAS 147-24-0PubChem CID 8980

Diphenhydramine Hydrochloride

Diphenhydramine hydrochloride appears as white or almost-white crystalline powder. Odorless with a bitter numbing taste. pH (5% aqueous solution) 4-6. (NTP, 1992) — CAMEO Chemicals

IUPAC name
2-benzhydryloxy-N,N-dimethylethanamine;hydrochloride
Molecular formula
C17H22ClNO
Molecular weight
291.8 g/mol
Exact mass
291.1389920 Da
Topological polar surface area
12.5 Ų
Hydrogen-bond donors
1
Hydrogen-bond acceptors
2
Covalent units
2
Defined stereocentres
0

Also known as

Diphenhydramine HClAllergivalBendylateAntitussiveDenydrylDibenilEldadrylFenylhist
16 more reported names
HydramineSilphenBeldinBelixDiphenDiphenhydramine.HClFelbenBenaDimedrol hydrochlorideHalbmondVicks Formula 44WehydrylResminBenzhydramine hydrochlorideBanophenDifenhydramine hydrochloride
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External database identifiers

Retrieved from NIH PubChem on 2026-09-02 by checksum-valid CAS matching. Chemical properties do not replace the regulatory decision on this page.

PubChem 2D chemical structure for CAS 58-73-1
CAS 58-73-1PubChem CID 3100

Diphenhydramine

Diphenhydramine is an ether that is the benzhydryl ether of 2-(dimethylamino)ethanol. It is a H1-receptor antagonist used as a antipruritic and antitussive drug. It has a role as a oneirogen, a sedative, a local anaesthetic, a H1-receptor antagonist, an antiparkinson drug, a muscarinic antagonist, an anti-allergic agent, an antiemetic, an antitussive, an antipruritic drug and an antidyskinesia agent. It is an ether and a tertiary amino compound. — ChEBI

IUPAC name
2-benzhydryloxy-N,N-dimethylethanamine
Molecular formula
C17H21NO
Molecular weight
255.35 g/mol
Exact mass
255.162314293 Da
XLogP3
3.3
Topological polar surface area
12.5 Ų
Hydrogen-bond donors
0
Hydrogen-bond acceptors
2
Covalent units
1
Defined stereocentres
0

Also known as

BenzhydramineAlledrylProbedrylDihidralAntistominumBenzhydraminumBenzhydroaminaDiphantine
16 more reported names
BaramineDermodrinDesentolDibondrinHistaxinBenylanDifenhidraminaDifenidraminaRestaminRigidylDiphenylhydramineDiphenhydraminumEthanamine, 2-(diphenylmethoxy)-N,N-dimethyl-O-Benzhydryldimethylaminoethanol2-(Benzhydryloxy)-N,N-dimethylethylamineFAR 90X2
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External database identifiers

Retrieved from NIH PubChem on 2026-09-02 by checksum-valid CAS matching. Chemical properties do not replace the regulatory decision on this page.

PubChem 2D chemical structure for CAS 88637-37-0
CAS 88637-37-0PubChem CID 174697

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
Topological polar surface area
145.0 Ų
Hydrogen-bond donors
4
Hydrogen-bond acceptors
9
Covalent units
2
Defined stereocentres
0

Also known as

Diphenhydramine citrate [USP]4OD433S209Diphenhydramine citrate (USP)2-(Diphenylmethoxy)-N,N-dimethylethylamine citrate (1:1)(2-(Diphenylmethoxy)ethyl)dimethylammonium dihydrogen 2-hydroxypropane-1,2,3-tricarboxylateRefChem:588810289-432-02-(Benzhydryloxy)-N,N-dimethylethanamine 2-hydroxypropane-1,2,3-tricarboxylate
16 more reported names
Diphenhydramine (citrate)Ethanamine, 2-(diphenylmethoxy)-N,N-dimethyl-, 2-hydroxy-1,2,3-propanetricarboxylate (1:1)UNII-4OD433S209C23H29NO8Ethanamine, 2-(diphenylmethoxy)-N,N-dimethyl-, 2-hydroxy-1,2,3-propanetricarboxylate (1:1); Diphenhydramine citrateEINECS 289-432-02-(Benzhydryloxy)-N,N-dimethylethanamine2-hydroxypropane-1,2,3-tricarboxylateDIPHENHYDRAMINE CITRATE [MART.]DIPHENHYDRAMINE CITRATE [VANDF]2-benzhydryloxy-N,N-dimethylethanamine,2-hydroxypropane-1,2,3-tricarboxylic acidDIPHENHYDRAMINE CITRATE [USP-RS]DIPHENHYDRAMINE CITRATE [WHO-DD]DIPHENHYDRAMINE CITRATE [ORANGE BOOK]DIPHENHYDRAMINE CITRATE [USP MONOGRAPH]2-benzhydryloxy-N,N-dimethyl-ethanamine;citric acid2-Hydroxypropane-1,2,3-tricarboxylic acid--2-(diphenylmethoxy)-N,N-dimethylethan-1-amine (1/1)
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External database identifiers

Retrieved from NIH PubChem on 2026-09-02 by checksum-valid CAS matching. Chemical properties do not replace the regulatory decision on this page.

Record details

Chemical name

Diphenhydramine (INN) and its salts

Regulatory information

Regulation

(EC) 2009/1223

See every entry this act set

Key data

CAS
58-73-1 / 147-24-0 / 88637-37-0
EC
200-396-7 / 205-687-2 / 289-432-0
Annex
II
Entry number
339

Inventory links for Diphenhydramine (INN) and its salts

Direct matches are limited for this record, so nearby entries from Annex II are shown as well.

Annex II 343
Nearby record in the same annex

Dioxane

CAS: 123-91-1
EC: 204-661-8

What Annex II means for Diphenhydramine (INN) and its salts

Diphenhydramine (INN) and its salts is listed as a prohibited substance under Annex II of EU Cosmetics Regulation 1223/2009 and must not be intentionally added. Article 17 separately addresses unintended small quantities that are technically unavoidable under good manufacturing practice and compatible with the Article 3 safety requirement.

Formulators must screen their ingredients and raw materials to ensure none contain this substance. Suppliers should provide documentation confirming absence when requested.

This record is linked to 1 CosIng inventory ingredient for name and identifier cross-reference. The page also surfaces 12 related annex records with overlapping identifiers, annex logic or naming patterns.

Compliance checklist

  • Verify this substance is absent from all raw materials and finished formulations.
  • Request absence confirmation or CoA from raw material suppliers.
  • Document the screening result in the Product Information File (PIF).

Frequently asked questions

Yes. Diphenhydramine (INN) and its salts is listed in Annex II of EU Cosmetics Regulation 1223/2009 and is prohibited as an intentionally added cosmetic ingredient. Article 17 provides a narrow exception for unintended small quantities that are technically unavoidable under good manufacturing practice, provided the product remains safe under Article 3.

CAS 58-73-1 / 147-24-0 / 88637-37-0 is the unique numerical identifier assigned to Diphenhydramine (INN) and its salts by the Chemical Abstracts Service. In cosmetic compliance work, the CAS number is used to cross-reference the substance across regulatory databases, raw material specifications and safety assessment reports. Multiple EU annex entries may share the same CAS number if the same substance appears under different conditions or in different annexes.

Use the INCI Checker tool on this site to paste your full ingredient list (INCI) and scan it against all Annex II–VI entries. The tool highlights any ingredients that match restricted, prohibited or allergen-flagged records. This is useful for rapid compliance screening of finished product formulas or raw material declarations.
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Source note for Annex II record Diphenhydramine (INN) and its salts

This page summarizes one Annex II record for Diphenhydramine (INN) and its salts from public European Commission cosmetic materials and adds linked inventory or identifier matches when available.

Use this record page to review Annex II conditions for Diphenhydramine (INN) and its salts, but confirm any final regulatory decision against the current official annex wording and source files.

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