Diphenhydramine HCl 25 mg

Product NDC: 69618-024
Requested package NDC: 69618-024-01
11-digit product format: 696180024
Labeler code: 69618
Product ID: 69618-024_2bc84c78-287a-70e5-e063-6394a90a01c3
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCl
Dosage form: CAPSULE
Route: ORAL
Labeler: Reliable 1 Laboratories LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-11-01
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 HCl 25 mg
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
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
32fa40ad-fed5-586f-e054-00144ff88e88	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
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69618-024-01	2023-03-29	C162847	48780-1	f386c64a-1896-0266-e053-dadaa90a7c1a	Diphenhydramine HCL 25 mg Capsules
69618-024-01	2023-01-30	C162847	48780-1	f386c64a-1896-0266-e053-dadaa90a7c1a	Diphenhydramine HCL 25 mg Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69618-024-01	Diphenhydramine HCl 25 mg	100 in 1 BOTTLE, PLASTIC	CAPSULE	100		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69618-024-01	EA - Each	69618-024	8be65923-d60d-4f3b-a337-8be559b0e6fc	1	2016-06-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69618-024	DIPHENHYDRAMINE HCL 25 MG (DIPHENHYDRAMINE HCL) CAPSULE [RELIABLE 1 LABORATORIES LLC]	6	Current NDC, Legacy NDC, 1 package rows	20250117_32fa40ad-fed5-586f-e054-00144ff88e88.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 117 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Severe Cold	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	cf2dd1fb-1d5b-428e-8c9a-a46dbd7cb645	2025-05-07	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	2b962d87-6ff5-4c0f-8504-e5b61c940612	2025-05-05	Warnings	Exact identifier application number: M012
Cough and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE LIQUID	CVS	2d13564a-e8d1-c357-e063-6394a90ad90e	2025-05-02	Warnings	Exact identifier application number: M012
SUDAFED OM Sinus Severe No Drip Nasal Mist with Cooling Menthol	OXYMETAZOLINE HYDROCHLORIDE	Kenvue Brands LLC	33fe0e49-3de5-8afd-e063-6294a90a0ad5	2025-05-02	Warnings	Exact identifier application number: M012
Daytime and Nighttime High Blood Pressure Cold and Flu Liquid	ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	CVS Pharmacy, Inc.	2d13964a-8cc4-f3dc-e063-6394a90aa105	2025-05-02	Warnings	Exact identifier application number: M012
DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML	DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML	AARNA USA INC.	32c26835-f54e-d7e5-e063-6294a90ae1c0	2025-04-30	Warnings	Exact identifier application number: M012
SUDAFED OM Sinus Severe No Drip Nasal Mist	OXYMETAZOLINE HYDROCHLORIDE	Kenvue Brands LLC	33e6239b-364a-0e62-e063-6294a90a5047	2025-04-29	Warnings	Exact identifier application number: M012
Childrens Allergy Relief	DIPHENHYDRAMINE HCL	CVS Pharmacy	8296049c-72fc-4200-9d45-c8e377314cf2	2025-04-29	Warnings	Exact identifier application number: M012
NIGHTTIME COLD AND FLU RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE	Aurohealth LLC	70e1bd25-c32e-491f-b383-91d6f74957a0	2025-04-28	Warnings	Exact identifier application number: M012
Childrens Allergy Relief Dye Free	DIPHENHYDRAMINE HCL	CVS Pharmacy	70914691-220c-4fce-9ee1-61a51e8864bc	2025-04-26	Warnings	Exact identifier application number: M012
Pseudoephedrine Hydrochloride	PSEUDOEPHEDRINE HYDROCHLORIDE	A-S Medication Solutions	810ce630-41be-4e15-b64a-d70f63abaf62	2025-04-24	Warnings	Exact identifier application number: M012
nasal	OXYMETAZOLINE HYDROCHLORIDE	H E B	5f945975-224f-43eb-b129-a61e3b25c4bb	2025-04-22	Warnings	Exact identifier application number: M012
Walgreens Severe Honey Lemon Throat Drops	MENTHOL	Walgreens	334a9348-2a44-5c94-e063-6394a90ae956	2025-04-21	Warnings	Exact identifier application number: M012
meijer Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Meijer, Inc.	1bd85bc3-e600-583d-e063-6294a90a7be1	2025-04-18	Warnings	Exact identifier application number: M012
Daytime Nighttime Ultra Concentrated	DAYTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	KROGER COMPANY	2be4a37b-44e1-8a8e-e063-6394a90a26a9	2025-04-17	Warnings	Exact identifier application number: M012
good neighbor pharmacy childrens cold and cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Amerisource Bergen	cde0fd43-771f-4528-bad2-5727efec5250	2025-04-17	Warnings	Exact identifier application number: M012
MUCUS RELIEF	GUAIFENESIN 400 MG	Pioneer Life Sciences, LLC	729ab412-f30b-4ad1-9d8f-1a5e1c48b118	2025-04-16	Warnings	Exact identifier application number: M012
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	9382c976-3067-4923-a38f-101d1c481e97	2025-04-11	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HCL LIQUID FILLED CAPSULES	Walmart Inc.	263d31c8-bdc2-a289-e063-6394a90a4aaa	2025-04-10	Warnings	Exact identifier application number: M012
CVS Wild Cherry Throat Drop	PECTIN	CVS	31f4b641-e9c0-786e-e063-6394a90aa253	2025-04-04	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	32fa40ad-fed5-586f-e054-00144ff88e88	6
1049909	diphenhydramine hydrochloride 25 MG Oral Capsule	SCD	32fa40ad-fed5-586f-e054-00144ff88e88	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69618-024-01	69618002401	100 CAPSULE in 1 BOTTLE, PLASTIC (69618-024-01)	100 capsule	2015-11-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diphenhydramine HCL 25 mg Capsules	Reliable 1 Laboratories LLC	2025-01-15	HUMAN OTC DRUG LABEL	6
Diphenhydramine HCL 25 mg Capsules	REMEDYREPACK INC.	2022-07-13	HUMAN OTC DRUG LABEL	7