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 116 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nuvicare NightTime Cold and Flu Softgel	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	NUVICARE LLC	37a88914-6234-4191-86f5-103c396c52af	2025-05-20	Warnings	Exact identifier application number: M012
Nuvicare DayTime Cold and Flu Softgel	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	NUVICARE LLC	1ea15426-4f3d-4a97-a590-6bd73bc6cbcd	2025-05-19	Warnings	Exact identifier application number: M012
Quality Choice Nasal	OXYMETAZOLINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION	3833e781-f6ee-4c6d-8756-d8ea2293a1f2	2025-05-19	Warnings	Exact identifier application number: M012
Quality Choice Nasal Mist Severe Congestion	OXYMETAZOLINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION	d45e99e5-ce66-4458-8d23-63a5dc7ae509	2025-05-19	Warnings	Exact identifier application number: M012
Quality Choicel Nasal Mist Extra Moisturizing	OXYMETAZOLINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION	460f0cc1-6a85-4d79-af87-a94fd151769e	2025-05-19	Warnings	Exact identifier application number: M012
Theraflu Flu Relief Max Strength Daytime Nighttime Combo Pack	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	812a093f-cf83-4f7a-927a-1b5695be7f90	2025-05-19	Warnings	Exact identifier application number: M012
MUCUS RELIEF	GUAIFENESIN	SDA Laboratories, Inc.	1fd16b06-0c3e-4a30-ae6a-7b1632189c20	2025-05-16	Warnings	Exact identifier application number: M012
Diphenhydramine HCl	DIPHENHYDRAMINE HCL	Akron Pharma Inc.	79a6b8c7-0e81-4a46-a854-31f449042709	2025-05-16	Warnings	Exact identifier application number: M012
Tussin DM Sugar free	DEXTROMETHORPHAN HBR AND GUAIFENESIN	AARNA USA, Inc.	3a521b65-fb35-4cc3-b826-88513afda0f9	2025-05-16	Warnings	Exact identifier application number: M012
Theraflu Flu Relief Max Strength Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	51c7628a-c7cf-498f-8fb1-db732e2b8b6e	2025-05-16	Warnings	Exact identifier application number: M012
BACTIMICINA CHILDRENS ALLERGY	DIPHENHYDRAMINE HYDROCHLORIDE	DLC Laboratories, Inc.	eaf554d4-a758-4ed6-bec5-d6cbfedae408	2025-05-15	Warnings	Exact identifier application number: M012
Bactimicina Childrens Cough and Cold	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	DLC Laboratories, Inc.	d407a583-07ae-4d47-b15a-24b5865c82da	2025-05-15	Warnings	Exact identifier application number: M012
Mucinex Nightshift Sinus Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDE	RB Health (US) LLC	35322238-d498-1a52-e063-6394a90ac9c4	2025-05-15	Warnings	Exact identifier application number: M012
Theraflu Flu Relief Max Strength Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	a1405038-80f2-45e5-bd8c-8c6b0ee348be	2025-05-15	Warnings	Exact identifier application number: M012
Cold Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	b919f0fe-fae0-4bd8-9ccd-d7569b2a7070	2025-05-13	Warnings	Exact identifier application number: M012
Childrens Robitussin Honey Nighttime Cough DM	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Haleon US Holdings LLC	6afaf85b-bf0c-4c99-acf3-a34f06be20f1	2025-05-13	Warnings	Exact identifier application number: M012
Robitussin Honey Severe Cough, Flu Plus Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	77be57fb-0ae5-4fad-97f3-b6a4b57383a9	2025-05-13	Warnings	Exact identifier application number: M012
Allergy	CHLORPHENIRAMINE MALEATE	Bryant Ranch Prepack	c948e612-a491-4ad0-adb9-cf31ef76e4d8	2025-05-12	Warnings	Exact identifier application number: M012
Maximum Strength Nighttime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Prodose, Inc.	c3d0b70f-d213-4e38-88ab-1c89d93a391d	2025-05-10	Warnings	Exact identifier application number: M012
Childrens Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Safeway, Inc.	c639a36d-c683-4a4d-90b7-eadec7464aa2	2025-05-08	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