Diphenhydramine HCL

Product NDC: 66267-779
11-digit product format: 662670779
Labeler code: 66267
Product ID: 66267-779_1fa77d0a-40f3-b54e-e063-6294a90a0375
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCL
Dosage form: CAPSULE
Route: ORAL
Labeler: NuCare Pharmaceuticals, Inc.
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2010-01-27
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 50 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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 8 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	66267-779-06	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	66267-779-06	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	66267-779-06	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	66267-779-06	`1332a3947898…`	`d4bfe170f9cd…`

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
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	50 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
1020477	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
489645ad-d7da-5f52-e054-00144ff8d46c	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
66267-779-06	2024-08-15	C162847	48780-1	f386c649-d3ae-0266-e053-dadaa90a7c1a	Drug Facts
66267-779-06	2023-01-30	C162847	48780-1	f386c649-d3ae-0266-e053-dadaa90a7c1a	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66267-779-06	Diphenhydramine HCL	6 in 1 BOTTLE	CAPSULE	6		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66267-779	DIPHENHYDRAMINE HCL CAPSULE [NUCARE PHARMACEUTICALS, INC.]	4	Current NDC, Legacy NDC, 1 package rows	20240816_489645ad-d7da-5f52-e054-00144ff8d46c.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 115 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
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

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
1020477	diphenhydrAMINE HCl 50 MG Oral Capsule	PSN	489645ad-d7da-5f52-e054-00144ff8d46c	4
1020477	diphenhydramine hydrochloride 50 MG Oral Capsule	SCD	489645ad-d7da-5f52-e054-00144ff8d46c	4
1020477	diphenhydramine HCl 50 MG Oral Capsule	SY	489645ad-d7da-5f52-e054-00144ff8d46c	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
66267-779-06	66267077906	6 CAPSULE in 1 BOTTLE (66267-779-06)	6 capsule	2017-02-15	0000-00-00	No	No	Current