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 145 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Severe Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	CVS Pharmacy	d40d6fd1-3f84-40ae-ab7e-04569eb41617	2024-10-30	Warnings	Exact identifier application number: M012
equaline nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	4e0c6ad6-81ef-4b0e-b2eb-44256faf7358	2024-10-30	Warnings	Exact identifier application number: M012
GOOD REMEDIES Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Strive Pharmaceuticals Inc.	24fbe2c0-7749-4c8a-e063-6394a90a7c6e	2024-10-30	Warnings	Exact identifier application number: M012
basic care nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	130e68d1-9048-49c1-beee-490eecaed2d9	2024-10-30	Warnings	Exact identifier application number: M012
Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Walgreen Company	02f3e739-3153-412f-b2cd-6f01dcd5875b	2024-10-30	Warnings	Exact identifier application number: M012
HealthWise Medicated Chest Rub	CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL	Veridian Healthcare	25a19d3e-37b3-50d5-e063-6394a90a97d1	2024-10-29	Warnings	Exact identifier application number: M012
Antigrip Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Pharmadel LLC	25a23a03-6110-f595-e063-6394a90a70fe	2024-10-29	Warnings	Exact identifier application number: M012
Antigrip Cough and Cold	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Pharmadel LLC	25a23e5e-302a-7b7f-e063-6294a90a0463	2024-10-29	Warnings	Exact identifier application number: M012
Antigrip Extra Strength	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Pharmadel LLC	25a26adf-fd90-bf57-e063-6294a90a4073	2024-10-29	Warnings	Exact identifier application number: M012
Menthol Cough Drops	MENTHOL	BOSTON NUTRACEUTICAL PRODUCTION, S.L	e82dac83-2910-44dc-e053-2995a90a38e1	2024-10-29	Warnings	Exact identifier application number: M012
TheraCare Medicated Chest Rub	CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL	Veridian Healthcare	d6e789c7-a55a-dc9a-e053-2a95a90a2bdb	2024-10-29	Warnings	Exact identifier application number: M012
Careone daytime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	American Sales Company	31187c98-6706-4962-91f6-022a390cda39	2024-10-28	Warnings	Exact identifier application number: M012
basic care daytime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	0100f86e-257f-4197-9849-3c4429cdf0f2	2024-10-28	Warnings	Exact identifier application number: M012
Premier Value Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN	PHARMACY VALUE ALLIANCE LLC	46bf124a-a44f-4066-b936-852d46da8f40	2024-10-28	Warnings	Exact identifier application number: M012
Signature Care Non drowsy Daytime Severe Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Safeway	25a26577-a9f8-49cb-9d75-d8c471e4aaf6	2024-10-28	Warnings	Exact identifier application number: M012
daytime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Kroger Company	2d5d7f1a-1d5d-4fc1-86f6-3b4aa073565e	2024-10-28	Warnings	Exact identifier application number: M012
Leader Daytime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Cardinal Health 110, LLC. dba Leader	d38537c6-9553-4e93-a83e-11ed48c955ab	2024-10-28	Warnings	Exact identifier application number: M012
Severe Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	CVS Pharmacy	2b3a1997-f382-4843-a44b-d80d1ad21a90	2024-10-28	Warnings	Exact identifier application number: M012
Premier Value Tussin Cough Long Acting	DEXTROMETHORPHAN HBR	Chain Drug Consortium, LLC	0e393287-5bb8-458b-98c4-55fa16674d06	2024-10-28	Warnings	Exact identifier application number: M012
daytime cold flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Meijer, Inc.	1740ccfc-6e68-46f4-a1ba-48fe092f0aa0	2024-10-28	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
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