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 141 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
basic care daytime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	50528d29-ce8c-4efb-a86c-17246b017db0	2024-11-07	Warnings	Exact identifier application number: M012
cooling severe daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	CVS Pharmacy	d4a21760-b2bd-4e26-bff0-6fc1b05d26b3	2024-11-07	Warnings	Exact identifier application number: M012
dg health day time severe cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Dolgencorp, LLC	60870311-3234-44ba-95dd-09cf4ea3d508	2024-11-07	Warnings	Exact identifier application number: M012
adult dm max cough and chest congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	Meijer Distribution Inc	3a6855c1-da6d-4fa9-81fe-d2e61355989f	2024-11-06	Warnings	Exact identifier application number: M012
oxymetazoline hcl	OXYMETAZOLINE HYDROCHLORIDE	A-S Medication Solutions	e51dfb62-40d0-4bec-9574-90057cb35bcc	2024-11-06	Warnings	Exact identifier application number: M012
Foster and Thrive Adult Tussin DM MAX	DEXTROMETHORPHAN HBR, GUAIFENESIN	Strategic Sourcing Services LLC	5f6e4d56-4a66-4dbd-97c8-550310dea358	2024-11-05	Warnings	Exact identifier application number: M012
Cough Drops Honey Lemon with Sugar	MENTHOL	Lidl US LLC	4ad9398f-7488-6eaf-e054-00144ff8d46c	2024-11-05	Warnings	Exact identifier application number: M012
rexall dm cough and congestion relief	DEXTROMETHORPHAN HBR, GUAIFENESIN	Dolgencorp, LLC	906838b1-a742-4728-944d-42b687b8cd59	2024-11-05	Warnings	Exact identifier application number: M012
tussin	DEXTROMETHORPHAN HBR, GUAIFENESIN	H E B	7c24c59c-7549-4c64-95f8-4bf755cd6f61	2024-11-05	Warnings	Exact identifier application number: M012
equate adult tussin dm max	DEXTROMETHORPHAN HBR, GUAIFENESIN	Wal-Mart Stores Inc	3592e000-a6c6-47fe-8bb0-9341c65c2959	2024-11-05	Warnings	Exact identifier application number: M012
tussin dm max	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Walgreen Company	756794b0-8d3b-4732-947c-a407caf400e2	2024-11-05	Warnings	Exact identifier application number: M012
basic care tussin dm max	DEXTROMETHORPHAN HBR, GUAIFENESIN	Amazon.com Services LLC	c6863e31-e1b9-40ff-ae2e-4aec86b4acc0	2024-11-05	Warnings	Exact identifier application number: M012
topcare tussin dm max	DEXTROMETHORPHAN HBR, GUAIFENESIN	Topco Associates LLC	94c35025-7bb4-4cb0-8bf3-4b44bb7fa59a	2024-11-05	Warnings	Exact identifier application number: M012
Childrens Sudafed PE NASAL DECONGESTANT	PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	4dfd46e4-b9f9-464d-aa47-e8fa9e526a5d	2024-11-04	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Safeway, Inc.	164b2559-2d3f-431e-a03c-07e86731af5c	2024-11-04	Warnings	Exact identifier application number: M012
tussin severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	H E B	7cc2c136-d1b7-4658-99bb-73bb1d140261	2024-11-04	Warnings	Exact identifier application number: M012
dg health tussin	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Dolgencorp Inc	a5d0ee70-d528-4a53-bf01-7bb13b364ed0	2024-11-04	Warnings	Exact identifier application number: M012
basic care tussin cf severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	bba9a17d-eb87-46f3-acee-c9dd34e5bfd4	2024-11-04	Warnings	Exact identifier application number: M012
topcare tussin cf max	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	b553b7e6-933b-49e3-97d3-22a4643a04b9	2024-11-04	Warnings	Exact identifier application number: M012
dg health nasal original	OXYMETAZOLINE HYDROCHLORIDE	Dolgencorp, LLC	fb209752-705a-4bb0-9298-8b70357f3911	2024-11-02	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