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 49 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sinus Pressure, Pain and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	97554f40-f9aa-4dbf-a6f2-de6197236ab4	2026-02-25	Warnings	Exact identifier application number: M012
Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Family Dollar Stores, Inc	1b50b865-3dfc-4b3f-86d5-5e91ca772445	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M012
Vaproizing	CAMPHOR	H E B	577fda09-588a-4c2e-ada5-eeda32d1aabe	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M012
Sore Throat Logenzes Sore Throat	BENZOCAINE AND MENTHOL	Major Pharmaceuticals	11416620-4892-44ba-9780-db27efff6743	2026-02-24	Warnings	Exact identifier application number: M012
Family Wellness SF Honey Lemon Cough Drops	MENTHOL	Family Dollar	4437853d-1f42-a41d-e063-6294a90aa81e	2026-02-24	Warnings	Exact identifier application number: M012
Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Best Choice (Valu Merchandisers Company)	64a93715-e7b1-4de1-8099-8ad6c585d517	2026-02-24	Warnings	Exact identifier application number: M012
Cough and Chest Congestion DM Daytime	DEXTROMETHORPHAN HBR, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	86af74c2-9183-4ee9-ad1e-d88dfc8bf47d	2026-02-24	Warnings	Exact identifier application number: M012
Cough DM Nighttime	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	39adf23e-76f3-42e1-a9f4-55feb38078e5	2026-02-24	Warnings	Exact identifier application number: M012
Revasol Tussin DM Cough Suppressant Expectorant	DEXTROMETHORPHAN HBR, GUAIFENESIN	Rnv LLC	4b7fd320-2f39-fa1a-e063-6294a90ada9e	2026-02-23	Warnings	Exact identifier application number: M012
Dimetapp Cold and Allergy	BROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE	Foundation Consumer Brands	47317865-4310-4f07-8815-f3130963307d	2026-02-23	Warnings	Exact identifier application number: M012
Dimetapp Cold and Cough and Dimetapp Nighttime Cold and Congestion	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND DIPHENHYDRAMINE HYRDOCHLORIDE	Foundation Consumer Brands	42720fa0-fcdd-4614-80b2-16d0ada345b1	2026-02-23	Warnings	Exact identifier application number: M012
Dimetapp Cold and Cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Foundation Consumer Brands	cc09a8c5-d173-4261-b838-96e6a16e2ff9	2026-02-23	Warnings	Exact identifier application number: M012
Dimetapp Nighttime Cold and Congestion	DIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE	Foundation Consumer Brands	96a1055f-e831-4f4b-8af3-7a41838c194c	2026-02-23	Warnings	Exact identifier application number: M012
Dimetapp Cold and Cough and Nighttime Cold and Congestion	DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE	Foundation Consumer Brands	1fbe1ce0-5e3e-4af5-a5f1-85ed12ced246	2026-02-23	Warnings	Exact identifier application number: M012
Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Better Living Brands, LLC	0948648c-1c5f-4225-a754-120ca8859f19	2026-02-23	Warnings, Adverse reactions	Exact identifier application number: M012
Revasol Tussin	GUAIFENESIN	Rnv LLC	f66dc593-9023-40e8-9cc3-0380b04b4305	2026-02-23	Warnings	Exact identifier application number: M012
Equate Vaporizing	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Wal-Mart Stores Inc	3006971b-784c-43fd-91a6-d96876bbf185	2026-02-23	Warnings	Exact identifier application number: M012
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Major Pharmaceuticals	04e70311-6412-4a20-84e3-f6e26d5f19ab	2026-02-20	Warnings	Exact identifier application number: M012
Banophen	DIPHENHYDRAMINE HCL	Major Pharmaceuticals	7f2b72cc-d4f7-431f-be61-c103cf8c489e	2026-02-20	Warnings	Exact identifier application number: M012
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Major Pharmaceuticals	dca04d80-e781-40b1-e053-2995a90a7010	2026-02-20	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