Benadryl Ultratabs

Product NDC: 67751-166
11-digit product format: 677510166
Labeler code: 67751
Product ID: 67751-166_2385ad34-3763-390b-e063-6394a90a12fd
Type: HUMAN OTC DRUG
Nonproprietary name: DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Navajo Manufacturing Company Inc.
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2016-09-22
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: Benadryl Ultratabs
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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1049630	Internal RxNorm lookup
1049632	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
76433e3c-142c-4704-8b2b-d602f008c377	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, Related label table
NDC	Effective	Related label
67751-166-01	2023-03-15	Benadryl Ultratabs
67751-166-02	2023-03-15	Benadryl Ultratabs
67751-166-01	2023-01-30	Benadryl Ultratabs
67751-166-02	2023-01-30	Benadryl Ultratabs

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67751-166-01	Benadryl Ultratabs	2 in 1 POUCH	TABLET, FILM COATED	2	4
67751-166-01	Benadryl Ultratabs	1 in 1 CARTON	TABLET, FILM COATED	1	4
67751-166-02	Benadryl Ultratabs	1 in 1 CARTON	TABLET, FILM COATED	1	4
67751-166-02	Benadryl Ultratabs	4 in 1 POUCH	TABLET, FILM COATED	4	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67751-166	BENADRYL ULTRATABS (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [NAVAJO MANUFACTURING COMPANY INC.]	4	Current NDC, Legacy NDC, 4 package rows	20241004_76433e3c-142c-4704-8b2b-d602f008c377.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 150 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	United Natural Foods, Inc. dba UNFI	08fda81a-bedd-4ff3-9c32-2066d2cea3f9	2024-10-17	Warnings	Exact identifier application number: M012
Guaifenesin	GUAIFENESIN	American Health Packaging	2fd702ea-3069-472c-b99e-c527f1375705	2024-10-17	Warnings	Exact identifier application number: M012
Mucus Relief Xpect	GUAIFENSIN, DEXTROMETHORPHAN	Selder, S.A. de C.V.	c2b49d10-b60f-3072-e053-2a95a90af004	2024-10-17	Warnings	Exact identifier application number: M012
Head Congestion plus Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	United Natural Foods, Inc. dba UNFI	1db914d3-8bba-405e-9bf9-9b1a5806284c	2024-10-17	Warnings	Exact identifier application number: M012
Cold Medicine XL3	ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE	Selder, S.A. de C.V.	e2c35fae-9dd6-51f2-e053-2995a90a1e9e	2024-10-17	Warnings	Exact identifier application number: M012
Cough and Cold XL3 Xtra	ACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDE	Selder, S.A. de C.V.	da5b31dd-becd-471a-9392-d0ee4b8f9539	2024-10-17	Warnings	Exact identifier application number: M012
Cold Medicine XL3 FORTE	ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE	MIDWAY IMPORTING INC.	58252f15-485c-3061-e053-2a91aa0a2320	2024-10-17	Warnings	Exact identifier application number: M012
Cold Medicine XL3	ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE	Midway Importing, Inc.	e41b9beb-e274-5c02-e053-2995a90ad0f8	2024-10-17	Warnings	Exact identifier application number: M012
Allergy Multi-Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	STRATEGIC SOURCING SERVICES LLC	38e70a28-eff2-4a48-b829-8cd68e80beef	2024-10-17	Warnings	Exact identifier application number: M012
Mucus Relief Xpect	GUAIFENSIN, DEXTROMETHORPHAN	Midway Importing Inc.	c2c8bd26-bbf1-c2e6-e053-2995a90a86a7	2024-10-17	Warnings	Exact identifier application number: M012
Antiflu Des Cough and Flu	ACETAMINOPHEN PHENYLEPHRINE HCL CHLORPHENIRAMINE MALEATE	Productos Farmaceuticos, S.A. de C.V.	dcf3897a-a793-6df7-e053-2995a90a25f8	2024-10-17	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	FSA STORE INC.	ec6aef90-ece1-4fe6-e053-2995a90a9310	2024-10-16	Warnings	Exact identifier application number: M012
Tukol MAX ACTION Cold, Sore Throat and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Genomma Lab USA, Inc	c8eebe64-00bf-436d-a9fc-1623401bebfa	2024-10-16	Warnings	Exact identifier application number: M012
Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Discount Drug Mart	4f42c8d2-0538-4bcd-aac0-e26103a30499	2024-10-16	Warnings	Exact identifier application number: M012
Tukol MAX ACTION Severe Congestion and Cough	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Genomma Lab USA, Inc	9ac3e24a-d18a-48fc-8005-55393085d57b	2024-10-16	Warnings	Exact identifier application number: M012
Nighttime Cough	DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	45471fdd-c4cd-46ad-a932-aa37327e8a41	2024-10-16	Warnings	Exact identifier application number: M012
DG Health Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Dolgencorp Inc	8cb15a8d-c836-4167-bc6b-dd20a34076e8	2024-10-16	Warnings	Exact identifier application number: M012
basic care nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Amazon.com Services LLC	f4497e56-c69d-4ae9-bd81-80bf2ee1b17f	2024-10-15	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	FOODHOLD U.S.A., LLC	8256c1fb-683d-56ab-e053-2a91aa0ac197	2024-10-15	Warnings	Exact identifier application number: M012
SINUS SEVRE	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	RETAIL BUSINESS SERVICES , LLC.	9f9586e3-a8b4-4060-e053-2995a90aa068	2024-10-15	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
1049632	Benadryl 25 MG Oral Tablet	PSN	76433e3c-142c-4704-8b2b-d602f008c377	4
1049630	diphenhydrAMINE HCl 25 MG Oral Tablet	PSN	76433e3c-142c-4704-8b2b-d602f008c377	4
1049632	diphenhydramine hydrochloride 25 MG Oral Tablet [Benadryl]	SBD	76433e3c-142c-4704-8b2b-d602f008c377	4
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	76433e3c-142c-4704-8b2b-d602f008c377	4
1049632	Benadryl 25 MG Oral Tablet	SY	76433e3c-142c-4704-8b2b-d602f008c377	4
1049632	Benadryl Allergy Ultratab 25 MG Oral Tablet	SY	76433e3c-142c-4704-8b2b-d602f008c377	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67751-166-01	67751016601	1 POUCH in 1 CARTON (67751-166-01) / 2 TABLET, FILM COATED in 1 POUCH	1 pouch	2016-09-22	0000-00-00	No	No	Current
67751-166-02	67751016602	1 POUCH in 1 CARTON (67751-166-02) / 4 TABLET, FILM COATED in 1 POUCH	1 pouch	2016-09-22	0000-00-00	No	No	Current