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 117 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
REVASOL CHILDRENS ALLERGY	DIPHENHYDRAMINE HCL	Rnv LLC	3143137f-ef42-5358-e063-6394a90a8ed1	2025-03-26	Warnings	Exact identifier application number: M012
Rompe Pecho SF FLU	DEXTROMETHORPHAN, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE	Efficient Laboratories Inc	bc10695a-9664-4ce3-82bb-820da06129fa	2025-03-26	Warnings	Exact identifier application number: M012
SUPRESS-PE Pediatric	GUIAFENESIN, PHENYLEPHRINE HCL	Kramer Novis	a474171d-5c29-4a80-9d37-00613796211a	2025-03-26	Warnings	Exact identifier application number: M012
Guaifenesin DM	DEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESIN	Innovida Pharmaeutique Corporation	dd3f806b-2470-4055-94e1-18adac811025	2025-03-25	Warnings	Exact identifier application number: M012
Foster and Thrive childrens cold cough relief dm	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Strategic Sourcing Services LLC	38b710e3-1d01-4ff4-a6b6-44936f277f49	2025-03-25	Warnings	Exact identifier application number: M012
Revasol Tussin DM Max with Honey	DEXTROMETHORPHAN HBR AND GUAIFENESIN	Rnv LLC	30da9255-c93a-84d6-e063-6394a90a7c2a	2025-03-21	Warnings	Exact identifier application number: M012
REVASOL NIGHTTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE	Rnv LLC	30dfd8f7-4cc6-d4f2-e063-6394a90aa9c9	2025-03-21	Warnings	Exact identifier application number: M012
Chest Congestion Relief	GUAIFENESIN	Meijer, Inc.	261a79b3-5704-76f2-e063-6394a90a5ac6	2025-03-20	Warnings	Exact identifier application number: M012
Rompe Tos X Children	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	OPMX LLC	05cc932d-b412-0710-e063-6394a90a87f6	2025-03-19	Warnings	Exact identifier application number: M012
Rompe Tos X Adults	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	OPMX LLC	05abb2db-d22e-90b5-e063-6294a90ace3f	2025-03-19	Warnings	Exact identifier application number: M012
Sinus Head Congestion	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE	VIVUNT PHARMA LLC	30a07773-bd6f-b9f2-e063-6394a90ab8aa	2025-03-18	Warnings	Exact identifier application number: M012
Halls Sugar Free Black Cherry	MENTHOL	Mondelez Global LLC	bd2a311a-bf0c-4365-af9b-76675c243b22	2025-03-16	Warnings	Exact identifier application number: M012
Medicated Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	TARGET CORPORATION	fbca9627-5e12-048a-e053-6294a90a6e0f	2025-03-15	Warnings	Exact identifier application number: M012
Medicated Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	DOLGENCORP, INC.	0655688e-7c42-507f-e063-6294a90ae498	2025-03-15	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	CVS PHARMACY, INC	1b8d5494-1fcf-4cd0-acc0-34f17d577bd7	2025-03-14	Warnings	Exact identifier application number: M012
Ultra Concentrated Daytime COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	PuraCap Pharmaceutical LLC	300b2357-933b-fe9a-e063-6294a90aa4b9	2025-03-11	Warnings	Exact identifier application number: M012
Ultra Concentrated Nighttime COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	PuraCap Pharmaceutical LLC	300bf27f-744f-7366-e063-6394a90acbcb	2025-03-11	Warnings	Exact identifier application number: M012
Daytime COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	PuraCap Pharmaceutical LLC	300c7c7b-ea0b-3650-e063-6294a90a65e8	2025-03-11	Warnings	Exact identifier application number: M012
Rompe Pecho Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	EFFICIENT LABORATORIES INC	2ec319a8-92bf-4552-86dd-37cbce18980f	2025-03-11	Warnings	Exact identifier application number: M012
HISTEX-DM New Formulation	DEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCI, AND TRIPROLIDINE HCI	Allegis Pharmaceuticals, LLC	30010401-e5b4-2bd9-e063-6394a90a0b0b	2025-03-10	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