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 135 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	9fc3fb4b-8906-4f4b-bc5d-9cf1e38fd6c6	2024-11-21	Warnings	Exact identifier application number: M012
Dextromethorphan HBr 15 mg	DEXTROMETHORPHAN HBR	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	028b025e-2dde-4bef-ba7b-61774e855b4b	2024-11-21	Warnings	Exact identifier application number: M012
Daytime Severe Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	PuraCap Pharmaceutical LLC	856cb3c3-8f32-4285-8c13-25f01779a31a	2024-11-21	Warnings	Exact identifier application number: M012
Night Time Severe Cold and Flu Relief	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDE	PuraCap Pharmaceutical LLC	3375a059-2939-438e-92b5-a7f1952bbb22	2024-11-21	Warnings	Exact identifier application number: M012
NiteTime Cold/Flu, Multi-Symptom Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Wal-Mart Stores Inc	9033bf94-f444-4488-b717-050d04dee388	2024-11-21	Warnings	Exact identifier application number: M012
Day and Night Sinus Relief Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores, Inc.	4b554ce8-9a6a-444f-b5ea-63359bbc0653	2024-11-21	Warnings	Exact identifier application number: M012
Day Severe Cold and Night Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores, Inc.	7492b381-9eca-4b07-b356-63fdaea14f81	2024-11-21	Warnings	Exact identifier application number: M012
Severe sinus Congestion Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	FOODHOLD U.S.A., LLC	e173bec9-14df-4535-a023-47d8cda8d4ec	2024-11-21	Warnings	Exact identifier application number: M012
COLD FLU and SORE THROAT RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	FOODHOLD U.S.A., LLC	1161e5dc-0677-4fb9-964f-971a508098b6	2024-11-21	Warnings	Exact identifier application number: M012
Night Time Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Retail Business Services, LLC	fc8c70d6-6be5-4f12-84b0-125fc82149ec	2024-11-21	Warnings	Exact identifier application number: M012
12 Hour Original Nasal Decongestant	NASAL SPRAY	WinCo Foods LLC	b3b6065a-56da-45e9-b89d-f6553bc181c9	2024-11-21	Warnings	Exact identifier application number: M012
Family Wellness Oxymetazoline Sinus Severe	OXYMETAZOLINE	FAMILY DOLLAR (Family Wellness)	13237d31-c60a-49f8-9b96-4414cf766a08	2024-11-21	Warnings	Exact identifier application number: M012
DayTime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	5b55d1df-275b-40d8-bde3-fc43313b7eb3	2024-11-20	Warnings	Exact identifier application number: M012
Halls Green Apple	MENTHOL	Mondelez Global LLC	1bb8dcb2-c3a8-a64e-e063-6294a90ae4a2	2024-11-20	Warnings	Exact identifier application number: M012
Halls Blueberry	MENTHOL	Mondelez Global LLC	275a6935-ea44-486e-e063-6394a90ae19a	2024-11-20	Warnings	Exact identifier application number: M012
No Drip Nasal Mist	OXYMETAZOLINE SPRAY	Walgreens Company	234bd567-4e3c-419f-a000-fdfc28cafc8b	2024-11-20	Warnings	Exact identifier application number: M012
NICE Assorted Cough Drops	MENTHOL	Leosons Overseas Corp	96db0f37-41cc-1ebd-e053-2a95a90a3215	2024-11-19	Warnings	Exact identifier application number: M012
Nice Cherry Cough Drops	MENTHOL	Leosons Overseas Corp	98e52604-6e41-6408-e053-2995a90a6bc8	2024-11-19	Warnings	Exact identifier application number: M012
NICE Citrus Cough Drops	MENTHOL	Leosons Overseas Corp	96d9527d-9bf9-ce82-e053-2995a90aff0c	2024-11-19	Warnings	Exact identifier application number: M012
NICE Menthol Cough Drops	MENTHOL	Leosons Overseas Corp	96d77897-475c-482c-e053-2995a90a2da4	2024-11-19	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