diphenhydramine hydrochloride

Product NDC: 76457-002
11-digit product format: 764570002
Labeler code: 76457
Product ID: 76457-002_0b586170-9b5f-74dc-e063-6394a90aa09b
Type: HUMAN OTC DRUG
Nonproprietary name: DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: Simpex Pharma Pvt. Ltd
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-02-09
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 25 mg/1
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: diphenhydramine hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
TC2D6JAD40	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1049630	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
82771f6a-8b3d-4ffa-8b35-09c2faf3582c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76457-002-00	diphenhydramine hydrochloride	100 in 1 BOTTLE	TABLET	100		5
76457-002-00	diphenhydramine hydrochloride	1 in 1 CARTON	TABLET	1		5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE TABLET [SIMPEX PHARMA PVT. LTD]	1
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	DIPHENHYDRAMINE HYDROCHLORIDE TABLET [SIMPEX PHARMA PVT. LTD]	1
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	DIPHENHYDRAMINE HYDROCHLORIDE TABLET [SIMPEX PHARMA PVT. LTD]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	DIPHENHYDRAMINE HYDROCHLORIDE TABLET [SIMPEX PHARMA PVT. LTD]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIPHENHYDRAMINE HYDROCHLORIDE TABLET [SIMPEX PHARMA PVT. LTD]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	DIPHENHYDRAMINE HYDROCHLORIDE TABLET [SIMPEX PHARMA PVT. LTD]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DIPHENHYDRAMINE HYDROCHLORIDE TABLET [SIMPEX PHARMA PVT. LTD]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DIPHENHYDRAMINE HYDROCHLORIDE TABLET [SIMPEX PHARMA PVT. LTD]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	DIPHENHYDRAMINE HYDROCHLORIDE TABLET [SIMPEX PHARMA PVT. LTD]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	DIPHENHYDRAMINE HYDROCHLORIDE TABLET [SIMPEX PHARMA PVT. LTD]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIPHENHYDRAMINE HYDROCHLORIDE TABLET [SIMPEX PHARMA PVT. LTD]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DIPHENHYDRAMINE HYDROCHLORIDE TABLET [SIMPEX PHARMA PVT. LTD]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DIPHENHYDRAMINE HYDROCHLORIDE TABLET [SIMPEX PHARMA PVT. LTD]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	DIPHENHYDRAMINE HYDROCHLORIDE TABLET [SIMPEX PHARMA PVT. LTD]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76457-002	DIPHENHYDRAMINE HYDROCHLORIDE TABLET [SIMPEX PHARMA PVT. LTD]	5	Current NDC, Legacy NDC, 2 package rows	20231201_82771f6a-8b3d-4ffa-8b35-09c2faf3582c.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 64 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dologesic DF	ACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE	Llorens Pharmaceutical International Division	55768b45-fd98-4779-85b6-6a50c628677e	2025-12-31	Warnings	Exact identifier application number: M012
Triponel	DEXTROMETHORPHAN HBR, PSEUFOEPHEDRINE HCL, TRIPROLIDINE HCL	Llorens Pharmaceutical International Division, Inc.	e9a8deb4-0595-4f0f-ac15-f936f15aca88	2025-12-31	Warnings	Exact identifier application number: M012
Tusnel	DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL	Llorens Pharmaceutical International Division	805dc611-355a-4af5-bf19-464c3290c5c6	2025-12-31	Warnings	Exact identifier application number: M012
Tusnel Pediatric	DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL	Llorens Pharmaceutical International Division	82f447f6-4f1b-4f56-9d7d-ea02adeea88c	2025-12-31	Warnings	Exact identifier application number: M012
Triponel	DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCL	LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION	cc774d33-96ce-4992-ad30-3cb03b0d119d	2025-12-31	Warnings	Exact identifier application number: M012
Tusnel SF	DEXTROMETHORPHAN HBR, GUAIFENESIN	Llorens Pharmaceutical International Division, Inc.	cb43b4df-5ccc-416e-abcd-98f079b3f2bb	2025-12-31	Warnings	Exact identifier application number: M012
Tusnel Cough Suppressant Expectorant	DEXTROMETHORPHAN HBR, GUAIFENESIN	Llorens Pharmaceutical International Division, Inc.	af71cdbc-33d6-4303-b494-d7321721d3be	2025-12-31	Warnings	Exact identifier application number: M012
Tusnel Pediatric DM	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Llorens Pharmaceutical International Division, Inc.	63541753-de8d-42fe-a9b3-a5eac3fcdca4	2025-12-31	Warnings	Exact identifier application number: M012
Tusnel Pediatric Drops	GUAIFENESIN, PHENYLEPHRINE HCL	LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION	dbf7c43a-7b29-4c70-9e6d-8a7ea924a9d7	2025-12-31	Warnings	Exact identifier application number: M012
Tusnel DM Pediatric	DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL	Llorens Pharmaceutical International Division	d915eab8-013e-4ce3-b358-0d531e5ca1ba	2025-12-31	Warnings	Exact identifier application number: M012
Tusnel-DM Pediatric	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION	64e36b02-b5be-4d20-8818-cb5b23596671	2025-12-31	Warnings	Exact identifier application number: M012
Honey Lemon Cough Drops	MENTHOL	Bestco Inc.	77f89a64-f4a4-f909-e053-2a91aa0ad44d	2025-12-31	Warnings	Exact identifier application number: M012
Honey Lemon Cough Drops	MENTHOL	Bestco Inc.	77f65f59-7ea1-adce-e053-2991aa0a6f1f	2025-12-31	Warnings	Exact identifier application number: M012
Sugar Free Honey Lemon Cough Drops	MENTHOL	Bestco Inc.	77f9e176-d87a-beed-e053-2991aa0aac20	2025-12-31	Warnings	Exact identifier application number: M012
Sugar Free Cherry Cough Drops	MENTHOL	Bestco Inc.	7858f380-bef7-3d30-e053-2a91aa0a7ea6	2025-12-31	Warnings	Exact identifier application number: M012
Strawberry Cough Drops	MENTHOL	BestCo Inc.	26a22cfd-395b-4ffb-e054-00144ff88e88	2025-12-31	Warnings	Exact identifier application number: M012
Limpia Pecho	DEXTROMETHORPHAN HBR, GUAIFENESIN	Llorens Pharmaceutical International Division, Inc.	cbaea3e4-4c4b-4ff9-ae6f-95b6a2d3faf3	2025-12-31	Warnings	Exact identifier application number: M012
Cherry Sore Throat Lozenges	BENZOCAINE	Bestco Inc.	737efd41-2d59-6013-e053-2a91aa0a6c63	2025-12-31	Warnings	Exact identifier application number: M012
Best Health Menthol Cough Drops	MENTHOL	Bestco LLC	dda66a3c-9006-ff1a-e053-2a95a90abfb3	2025-12-31	Warnings	Exact identifier application number: M012
Rynex DM	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Edwards Pharmaceuticals, Inc	7be2c282-24ba-4f19-9b14-872d3f5746a7	2025-12-31	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE	147-24-0	DIPHENHYDRAMINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1049630	diphenhydrAMINE HCl 25 MG Oral Tablet	PSN	82771f6a-8b3d-4ffa-8b35-09c2faf3582c	5
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	82771f6a-8b3d-4ffa-8b35-09c2faf3582c	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76457-002-00	76457000200	1 BOTTLE in 1 CARTON (76457-002-00) / 100 TABLET in 1 BOTTLE	1 bottle	2018-02-09	0000-00-00	No	No	Current