Home NDC 49483-329 DIPHENHYDRAMINE HYDROCHLORIDE
Product NDC 49483-329
11-digit product format 494830329
Labeler code 49483
Product ID 49483-329_7d3b9a35-9e04-4289-e053-2a91aa0a5042
Type HUMAN OTC DRUG
Nonproprietary name DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form TABLET, COATED
Route ORAL
Labeler Time-Cap Labs, Inc
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2010-03-01
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 Additional Listing Data#
Finished product Yes
Brand name base DIPHENHYDRAMINE HYDROCHLORIDE
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1049630 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49483-329-00 DIPHENHYDRAMINE HYDROCHLORIDE 100000 in 1 CARTON TABLET, COATED 100000 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED [TIME-CAP LABS, INC] 1 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED [TIME-CAP LABS, INC] 1 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED [TIME-CAP LABS, INC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED [TIME-CAP LABS, INC] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED [TIME-CAP LABS, INC] 1 DIBASIC CALCIUM PHOSPHATE DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED [TIME-CAP LABS, INC] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED [TIME-CAP LABS, INC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED [TIME-CAP LABS, INC] 1 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED [TIME-CAP LABS, INC] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED [TIME-CAP LABS, INC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED [TIME-CAP LABS, INC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED [TIME-CAP LABS, INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49483-329 DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED [TIME-CAP LABS, INC] 2 Current NDC, Legacy NDC, 1 package rows 20181218_ed899055-0cbb-45bd-92c8-cbef2fc7c361.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 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 49483-329-00 49483032900 100000 TABLET, COATED in 1 CARTON (49483-329-00) 2018-12-17 0000-00-00 No No Current