Home NDC 45802-358 diphenhydramine hcl and zinc acetate
Product NDC 45802-358
11-digit product format 458020358
Labeler code 45802
Product ID 45802-358_888ad1f9-aeb1-4778-8d5a-734e734036e6
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine Hydrochloride, Zinc Acetate
Dosage form CREAM
Route TOPICAL
Labeler Padagis Israel Pharmaceuticals Ltd
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2005-12-05
Substance DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Active strength 2; .1 g/100g; g/100g
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 diphenhydramine hcl and zinc acetate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 2 g/100g ZINC ACETATE .1 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination TC2D6JAD40 Internal UNII lookup FM5526K07A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1087026 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 45802-358-03 diphenhydramine hcl and zinc acetate 1 in 1 CARTON CREAM 1 7 45802-358-03 diphenhydramine hcl and zinc acetate 28 g in 1 TUBE CREAM 28 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 DIPHENHYDRAMINE HCL AND ZINC ACETATE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PERRIGO NEW YORK INC] 2 ZINC ACETATE ACTIVE INGREDIENT FM5526K07A DIPHENHYDRAMINE HCL AND ZINC ACETATE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PERRIGO NEW YORK INC] 2 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M DIPHENHYDRAMINE HCL AND ZINC ACETATE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PERRIGO NEW YORK INC] 2 ZINC ACTIVE MOIETY J41CSQ7QDS DIPHENHYDRAMINE HCL AND ZINC ACETATE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PERRIGO NEW YORK INC] 2 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN DIPHENHYDRAMINE HCL AND ZINC ACETATE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PERRIGO NEW YORK INC] 2 DIAZOLIDINYL UREA INACTIVE INGREDIENT H5RIZ3MPW4 DIPHENHYDRAMINE HCL AND ZINC ACETATE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PERRIGO NEW YORK INC] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T DIPHENHYDRAMINE HCL AND ZINC ACETATE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PERRIGO NEW YORK INC] 2 PEG-2 STEARATE INACTIVE INGREDIENT 94YQ11Y95F DIPHENHYDRAMINE HCL AND ZINC ACETATE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PERRIGO NEW YORK INC] 2 PEG-20 STEARATE INACTIVE INGREDIENT NBX892EA57 DIPHENHYDRAMINE HCL AND ZINC ACETATE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PERRIGO NEW YORK INC] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 DIPHENHYDRAMINE HCL AND ZINC ACETATE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PERRIGO NEW YORK INC] 2 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH DIPHENHYDRAMINE HCL AND ZINC ACETATE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PERRIGO NEW YORK INC] 2 WATER INACTIVE INGREDIENT 059QF0KO0R DIPHENHYDRAMINE HCL AND ZINC ACETATE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PERRIGO NEW YORK INC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 45802-358 DIPHENHYDRAMINE HCL AND ZINC ACETATE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PADAGIS ISRAEL PHARMACEUTICALS LTD] 6 Current NDC, Legacy NDC, 2 package rows 20240830_6d7a7615-9ae7-4c55-8a84-dba746f535d7.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 44 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lidocaine HCI LIDOCAINE HCI Trifluent Pharma, LLC 47f7f06b-720e-eeec-e063-6294a90ae823 2026-01-09 Warnings Exact identifier application number: M017 Lidocaine LIDOCAINE Bellus Medical, LLC 60cb89f6-e326-0773-e053-2a91aa0a33dd 2026-01-09 Warnings Exact identifier application number: M017 Tetracaine TETRACAINE Bellus Medical, LLC 60cabb5f-606b-7a74-e053-2a91aa0ac024 2026-01-09 Warnings Exact identifier application number: M017 Benzocaine BENZOCAINE Bellus Medical, LLC 60cafbaf-8ec6-46a5-e053-2a91aa0af11f 2026-01-09 Warnings Exact identifier application number: M017 PRAX PRAMOXINE HYDROCHLORIDE AvPAK dc646399-91ba-5cc1-e053-2a95a90a4f9c 2026-01-09 Warnings Exact identifier application number: M017 2.5% Menthol PAIN RELIEF MENTHOL Universal Distribution Center LLC c842544a-6aea-42af-a77e-7b202371b387 2026-01-09 Warnings Exact identifier application number: M017 4% Menthol PAIN RELIEF MENTHOL Universal Distribution Center LLC 7fb95135-4151-4ef4-bb6d-75251cafff6c 2026-01-09 Warnings Exact identifier application number: M017 Meijer Extra Strength Cold And Hot TherapyPain Relieving Topical Analgesic MENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATE Meijer Distribution, Inc 781f89c0-94ab-48de-9e0b-decb37bcde46 2026-01-09 Warnings Exact identifier application number: M017 LIDOCAINE PAIN RELIEVING Gel-Patch LIDOCAINE Guangzhou Zhupuyou E-commerce Co., Ltd 2159fb73-cf6c-184a-e063-6394a90a1d14 2026-01-08 Warnings Exact identifier application number: M017 PAIN RELIEF Gel-Patch LIDOCAINE, MENTHOL Guangzhou Zhupuyou E-commerce Co., Ltd 22d9ce20-1cb6-c5bd-e063-6394a90a9eca 2026-01-08 Warnings Exact identifier application number: M017 AY BENDITO - THERMOACTIVE CAMPHOR, MENTHOL AY BENDITO INT'L THERMO ANALGETICS ROLL-ON 76ef713b-e23d-7b98-e053-2991aa0aad51 2026-01-08 Warnings Exact identifier application number: M017 AY BENDITO - THERMOACTIVE CAMPHOR, MENTHOL AY BENDITO INTERNATIONAL, INC bbf0ca84-2800-d222-e053-2995a90ad8f3 2026-01-08 Warnings Exact identifier application number: M017 Capsaicin CAPSAICIN AvPAK ef5b0db6-8f0a-4f8e-e053-2995a90a22b7 2026-01-08 Warnings Exact identifier application number: M017 Capsaicin Topical Analgesic CAPSAICIN AvPAK ef597423-cd01-7324-e053-2a95a90aa1ba 2026-01-08 Warnings Exact identifier application number: M017 Capsaicin External Analgesic CAPSAICIN AvPAK ef5a3846-1d2f-7023-e053-2a95a90ad716 2026-01-08 Warnings Exact identifier application number: M017 Capsaicin CAPSAICIN AvPAK ef5bb0fa-afc2-62d7-e053-2a95a90a37f4 2026-01-08 Warnings Exact identifier application number: M017 K2 Cold Therapy MENTHOL The Podiatree Co 60dce1ad-125e-396d-e053-2a91aa0a670f 2026-01-08 Warnings Exact identifier application number: M017 Burn Relief Aloe LIDOCAINE HCL Acutens 48c435fe-2670-4b80-bf01-923dc9354422 2026-01-08 Warnings Exact identifier application number: M017 Relieve A Pain LIDOCAINE Relieve A Pain LLC cafaa830-d894-4590-8928-d579cc791d79 2026-01-08 Warnings Exact identifier application number: M017 DZUL ARTHRITIS PAIN RELIEF MENTHOL Caball Sales, Inc. 159c301c-d462-bb2c-e063-6394a90a9e5a 2026-01-08 Warnings Exact identifier application number: M017
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 45802-358-03 45802035803 1 TUBE in 1 CARTON (45802-358-03) / 28 g in 1 TUBE 1 tube 2005-12-05 0000-00-00 No No Current