Diphenhydramine Hydrochloride

Product NDC: 72789-317
11-digit product format: 727890317
Labeler code: 72789
Product ID: 72789-317_56d551ca-b3ee-5d72-e063-6294a90af6c8
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-04-14
Marketing end: 2028-04-30
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 25 mg/1
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
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

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
1049909	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
879a7804-f3d4-4a3d-bc92-b473499d6c95	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	SPL version
72789-317-10	Diphenhydramine Hydrochloride	10 in 1 BOTTLE, PLASTIC	CAPSULE	10	6
72789-317-12	Diphenhydramine Hydrochloride	12 in 1 BOTTLE, PLASTIC	CAPSULE	12	6
72789-317-15	Diphenhydramine Hydrochloride	15 in 1 BOTTLE, PLASTIC	CAPSULE	15	6
72789-317-20	Diphenhydramine Hydrochloride	20 in 1 BOTTLE, PLASTIC	CAPSULE	20	6
72789-317-30	Diphenhydramine Hydrochloride	30 in 1 BOTTLE, PLASTIC	CAPSULE	30	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72789-317-10	EA - Each	72789-317	f73d9a2f-5d75-44a8-9b88-a6002474c00f	1	2023-06-06
72789-317-12	EA - Each	72789-317	2464e553-8f01-4953-a4b5-43e849652c09	1	2023-06-06
72789-317-15	EA - Each	72789-317	43a8de8b-5675-4f49-905b-f4b4f9b2e1fe	1	2023-06-06
72789-317-20	EA - Each	72789-317	d8399382-8242-44a4-b03d-72fef2afcbc7	1	2023-06-06
72789-317-30	EA - Each	72789-317	f3bbd72e-fe79-4c59-a9b9-412ef69161a0	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72789-317	DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	5	Current NDC, 5 package rows	20250221_879a7804-f3d4-4a3d-bc92-b473499d6c95.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 72 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DayTime Cold/Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	ARMY AND AIR FORCE EXCHANGE SERVICE	04f9134e-1311-4843-90db-9244b9e61e1d	2025-12-19	Warnings	Exact identifier application number: M012
Nighttime Cold/Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	ARMY AND AIR FORCE EXCHANGE SERVICE	029e6215-b72d-4fd0-8918-db1abcc4490a	2025-12-19	Warnings	Exact identifier application number: M012
DayTime and Nighttime Cold/Flu Relief Softgels - Combo Pack	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DOXYLAMINE SUCCINATE	ARMY AND AIR FORCE EXCHANGE SERVICE	5f680f37-b3db-450f-b8ca-f9e31a04dc04	2025-12-19	Warnings	Exact identifier application number: M012
Childrens Allergy Relief	DIPHENHYDRAMINE HCL	Marc Glassman, Inc.	e916ef86-ca73-42dd-83dc-6033f56d96f2	2025-12-19	Warnings	Exact identifier application number: M012
Original Night-Time MULTI-SYMPTOM COLD/FLU RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Discount Drug Mart	e243033b-6603-4c3e-a330-e7c7de51f69d	2025-12-19	Warnings	Exact identifier application number: M012
CHILDRENS ALLERGY	DIPHENHYDRAMINE HYDROCHLORIDE	Discount Drug Mart	6fa4f913-de83-4175-9dad-0dedab5b69a1	2025-12-19	Warnings	Exact identifier application number: M012
Day-Time COLD/FLU RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCL	Discount Drug Mart	426db906-9aa4-448f-a361-09c1516efc25	2025-12-19	Warnings	Exact identifier application number: M012
MAXIUM STRENGTH SEVERE CONGESTION and COUGH MAX	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Discount Drug Mart	f17385bc-82bb-4183-a4c9-067d8afb3757	2025-12-19	Warnings	Exact identifier application number: M012
MAXIUM STRENGTH DM MAX	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Discount Drug Mart	9654fdcd-d660-471f-bc5d-aa7dead7a4a8	2025-12-19	Warnings	Exact identifier application number: M012
Night Time Multi-Symptom Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Discount Drug Mart	8148c2b1-f6ec-4597-8e18-a6597cda5705	2025-12-19	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL 25 MG	NUVICARE LLC	621ba20e-75c5-42fb-9692-7800f764c978	2025-12-19	Warnings	Exact identifier application number: M012
Nasal Decongestant PE	PHENYLEPHRINE HCL 10 MG	NUVICARE LLC	4cde41dd-a0a7-45e7-aff3-ee9402dfdff2	2025-12-19	Warnings	Exact identifier application number: M012
COMBINATION PACK TopCare health DayTime SEVERE and NiteTime SEVERE Cold and Flu Relief SOFTGELS - 24 ct	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	ceb27ff3-cf42-44f9-9ee6-8ea86a0cbe3e	2025-12-19	Warnings	Exact identifier application number: M012
NeoTuss S/F Grape-Menthol Flavor	GUAIFENESIN, DEXTROMETHORPHAN HBR	DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals	2f3df82c-1926-5238-e063-6294a90a7bbf	2025-12-18	Warnings	Exact identifier application number: M012
NeoTuss S/F Grape-Menthol Flavor	GUAIFENESIN, DEXTROMETHORPHAN HBR	DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals	2fac3425-32f0-38d6-e063-6394a90a6e7a	2025-12-18	Warnings	Exact identifier application number: M012
NAFASOLINA	NAPHAZOLINE HYDROCHLORIDE	Doral Pharmamedics Inc DBA AG Marin Pharmaceuticals	30cade3d-208f-8594-e063-6394a90ad2a0	2025-12-18	Warnings	Exact identifier application number: M012
Honey Lemon Flavor Cough Drop	HONEY LEMON FLAVOR COUGH DROP	Army & Air Force Exchange Service	20ac8a20-206c-0024-e063-6394a90a9d06	2025-12-18	Warnings	Exact identifier application number: M012
Menthol Flavor Cough Drop	MENTHOL FLAVOR COUGH DROP	Army & Air Force Exchange Service	20ace10f-4257-b20e-e063-6394a90a3c7b	2025-12-18	Warnings	Exact identifier application number: M012
NeoTuss Plus	DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals	2fabd782-14dc-1d1b-e063-6394a90af428	2025-12-18	Warnings	Exact identifier application number: M012
NeoTuss Plus	DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals	2f3c6b38-7236-899b-e063-6294a90aabde	2025-12-18	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
1049909	diphenhydrAMINE HCl 25 MG Oral Capsule	PSN	879a7804-f3d4-4a3d-bc92-b473499d6c95	6
1049909	diphenhydramine hydrochloride 25 MG Oral Capsule	SCD	879a7804-f3d4-4a3d-bc92-b473499d6c95	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72789-317-10	72789031710	10 CAPSULE in 1 BOTTLE, PLASTIC (72789-317-10)	10 capsule	2023-04-05	2028-02-29	No	No	Historical
72789-317-12	72789031712	12 CAPSULE in 1 BOTTLE, PLASTIC (72789-317-12)	12 capsule	2023-04-05	2028-02-29	No	No	Historical
72789-317-15	72789031715	15 CAPSULE in 1 BOTTLE, PLASTIC (72789-317-15)	15 capsule	2023-04-05	2028-02-29	No	No	Historical
72789-317-20	72789031720	20 CAPSULE in 1 BOTTLE, PLASTIC (72789-317-20)	20 capsule	2023-04-05	2028-02-29	No	No	Historical
72789-317-30	72789031730	30 CAPSULE in 1 BOTTLE, PLASTIC (72789-317-30)	30 capsule	2023-04-05	2028-02-29	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diphenhydramine Hydrochloride - PD-Rx Pharmaceuticals, Inc.	PD-Rx Pharmaceuticals, Inc.	2026-07-17	HUMAN OTC DRUG LABEL	7