Home NDC 67751-166 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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength 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 74 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# 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