Home NDC 41520-778 careone allergy relief
Product NDC 41520-778
11-digit product format 415200778
Labeler code 41520
Product ID 41520-778_703c7305-4a5a-4d22-ae35-db8657dccf8c
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler American Sales Company
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2017-09-21
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 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 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…
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 careone allergy relief
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 41520-778-62 careone allergy relief 24 in 1 CARTON TABLET 24 5 41520-778-62 careone allergy relief 1 in 1 BLISTER PACK TABLET 1 5 41520-778-78 careone allergy relief 1 in 1 CARTON TABLET 1 5 41520-778-78 careone allergy relief 100 in 1 BOTTLE TABLET 100 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 41520-778 CAREONE ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [AMERICAN SALES COMPANY] 5 Current NDC, Legacy NDC, 4 package rows 20240719_ed4038fc-ab39-4567-9961-2b390b91b126.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 123 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 41520-778-62 41520077862 24 BLISTER PACK in 1 CARTON (41520-778-62) > 1 TABLET in 1 BLISTER PACK 24 blister pack 2017-09-21 0000-00-00 No No Current 41520-778-78 41520077878 1 BOTTLE in 1 CARTON (41520-778-78) / 100 TABLET in 1 BOTTLE 1 bottle 2017-09-21 0000-00-00 No No Current