Home NDC 36800-367 TopCare Allergy Relief
Product NDC 36800-367
11-digit product format 368000367
Labeler code 36800
Product ID 36800-367_f7a9bb07-e515-4474-9ac5-bbd7f336ee9f
Type HUMAN OTC DRUG
Nonproprietary name diphenhydramine hydrochloride
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler TOPCO ASSOCIATES LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-07-13
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 TopCare 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 1049909 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 36800-367-24 TopCare Allergy Relief 2 in 1 CARTON CAPSULE, LIQUID FILLED 2 4 36800-367-24 TopCare Allergy Relief 12 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 12 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-367 TOPCARE ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [TOPCO ASSOCIATES LLC] 4 Current NDC, Legacy NDC, 2 package rows 20241220_4c50233e-1dcb-427d-ba63-1538cf370061.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 98 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 36800-367-24 36800036724 2 BLISTER PACK in 1 CARTON (36800-367-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2 blister pack 2021-07-13 0000-00-00 No No Current