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 77 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Head Congestion plus Flu Severe PE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	VALU MERCHANDISERS COMPANY	f6401b58-8cf8-4067-e053-2995a90a68fc	2025-12-11	Warnings	Exact identifier application number: M012
Sinus Relief Pressure, Pain and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	VALU MERCHANDISERS COMPANY	b1ba37b8-4558-0808-e053-2995a90a9f5e	2025-12-11	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	VALU MERCHANDISERS COMPANY	b84f37bc-be37-4f2b-83ee-d7d134184490	2025-12-11	Warnings	Exact identifier application number: M012
Mucus Relief Cold Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	VALU MERCHANDISERS COMPANY	b1b7c7fc-1068-f486-e053-2a95a90a8e8c	2025-12-11	Warnings	Exact identifier application number: M012
Mucus Relief Cold and Flu All in One	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	VALU MERCHANDISERS COMPANY	b1b9e0da-2c54-8b31-e053-2995a90a690b	2025-12-11	Warnings	Exact identifier application number: M012
Sinus Relief Daytime, Nighttime, Maximum Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL	CVS PHARMACY	f6b3ca40-7638-477f-b800-4c28c40ff0a8	2025-12-11	Warnings	Exact identifier application number: M012
Allergy Relief	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Walgreen Company	0a6e3251-02e0-42c1-bdf3-51c77f88c17f	2025-12-11	Warnings	Exact identifier application number: M012
topcare nite time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Topco Associates LLC	516ab016-31f9-4829-8b94-2f968933093c	2025-12-11	Warnings	Exact identifier application number: M012
Sinus PE Congestion	DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Walgreen Company	5b9151b7-3e40-4f37-b3e0-4c0fa0115b71	2025-12-10	Warnings	Exact identifier application number: M012
Cough and Cold HBP	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Discount Drug Mart	2344c048-0550-4c31-b54e-a198910c490e	2025-12-10	Warnings	Exact identifier application number: M012
CVS Maximum Strength Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCL	CVS PHARMACY, INC	cf4eb4c4-68e0-4478-a81c-d3d1e66f5cc5	2025-12-10	Warnings	Exact identifier application number: M012
Tylenol Cold plus Flu Severe, Lil Drug Store	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Lil Drug Store Products, Inc	f395c196-62d7-47ff-b38d-af37adf5980b	2025-12-10	Warnings	Exact identifier application number: M012
Tylenol Sinus Severe, Lil Drug Store	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Lil Drug Store Products, Inc	88b68447-b016-4d5b-a5e3-c4ebccb14f8c	2025-12-10	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Family Dollar Services Inc	d956f1b8-91f8-424b-bb6c-704c445b6f4c	2025-12-10	Warnings	Exact identifier application number: M012
good neighbor pharmacy day time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Amerisource Bergen	e5c1bd96-d27d-49c1-b3b8-eee53a145ef5	2025-12-10	Warnings	Exact identifier application number: M012
NiteTime SEVERE Cold and Flu Relief SOFTGELS	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	3ffe67bf-2c66-61e6-e063-6394a90a7f8f	2025-12-10	Warnings	Exact identifier application number: M012
DayTime SEVERE Cold and Flu Relief SOFTGELS	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	3ffe0f43-b92a-f947-e063-6394a90ab72c	2025-12-10	Warnings	Exact identifier application number: M012
MAXIMUM STRENGTH Sinus Relief Day and Night SOFTGELS - 24 ct	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	a7285fe0-5a5b-42c4-be47-9a07a2ba75e8	2025-12-10	Warnings	Exact identifier application number: M012
Cold and Flu Relief Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Rite Aid Corporation	f9b8dbe1-7ff9-4320-850c-6e86e98d4393	2025-12-09	Warnings	Exact identifier application number: M012
Severe Nasal	OXYMETAZOLINE HYDROCHLORIDE 0.05%	ALAINA HEALTHCARE PRIVATE LIMITED	27747a10-8d1d-41c2-80b9-45452f3b9abc	2025-12-09	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