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 20 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Stud 100 Male Genital Desensitizer LIDOCAINE Pound International Corp d075656e-b13f-4a1d-bbb6-501e642698d5 2026-05-12 Warnings Exact identifier application number: M017 CeraVe Developed with Dermatologists Itch Relief Moisturizing PRAMOXINE HYDROCHLORIDE L'Oreal USA Products Inc 13ce57d0-b1c5-4685-ad7d-a562d9d8fc86 2026-05-12 Warnings Exact identifier application number: M017 Calamine Plus Pramoxine HCl CALAMINE PLUS SPRAY CVS Pharmacy db6f518d-3a0e-43f8-8d19-7382d9b7ff1c 2026-05-11 Warnings Exact identifier application number: M017 Cool and Heat MENTHOL AMERISOURCE BERGEN f2bb0e8e-c4cd-0e8c-e053-2995a90a6df7 2026-05-11 Warnings Exact identifier application number: M017 Instaflex Extra Strength Pain Relief Cream MENTHOL, METHYL SALICYLATE Healthy Directions, LLC d058c64d-0e4f-45aa-8f52-804961b562e3 2026-05-11 Warnings Exact identifier application number: M017 BonicaEaseX Hot Capsicum Pain Relieving CAPSICUM Planet (Anhui) Pharmaceutical Co.,Ltd ca6e48af-af6d-4808-a576-0319d2080d38 2026-05-11 Warnings Exact identifier application number: M017 BonicaEaseX Pain Relieving Lidocaine LIDOCAINE Planet (Anhui) Pharmaceutical Co., Ltd. 7486fe89-a377-4a37-997d-e3bd16b891a7 2026-05-11 Warnings Exact identifier application number: M017 YYSDMVY NUMBING Cream LIDOCAINE 4% NUMBING CREAM Jiangxi Yudexi Pharmaceutical Co., LTD 5195f5ec-8524-77f5-e063-6294a90abdc2 2026-05-11 Warnings Exact identifier application number: M017 Lightning X Burn Relief Gel LIDOCAINE HYDROCHLORIDE Nantong Health & Beyond Hygienic Products Inc. 515eb4cc-63af-c11d-e063-6294a90a13ca 2026-05-09 Warnings Exact identifier application number: M017 Albertson Lidocaine, Menthol Pain Relief Medicated Patch LIDOCAINE AND MENTHOL Safeway dc647647-90ec-6beb-e053-2a95a90a7982 2026-05-09 Warnings Exact identifier application number: M017 5 Elementum Lidocaine Male Genital Desensitizer LIDOCAINE MALE GENITAL DESENSITIZER MSVENTURESGROUP O 514b1738-886e-a95d-e063-6294a90aa707 2026-05-08 Warnings Exact identifier application number: M017 Kroger Muscle Rub Cream MENTHOL, CAMPHOR, METHYL SALICYLATE Kroger Co. 45c8c79a-b4b4-d4be-e063-6394a90a9251 2026-05-08 Warnings Exact identifier application number: M017 Walmart Equate Aloe Sunburn Relief Cooling LIDOCAINE WAL-MART STORES INC. 51540f6b-596f-bc47-e063-6294a90a46ae 2026-05-08 Warnings Exact identifier application number: M017 Capsaicin 0.035% cream CAPSAICIN Medcore LLC 0236e1e4-c26c-4fff-a83b-143ce26d93bf 2026-05-07 Warnings Exact identifier application number: M017 Lidocaine 4% Cream LIDOCAINE Medcore LLC 111cb421-ba3b-4772-ab60-d31eb4183168 2026-05-07 Warnings Exact identifier application number: M017 Lidocaine 5% Cream LIDOCAINE Medcore LLC 15d02b42-bf8b-486a-a081-f6d17cc11ec7 2026-05-07 Warnings Exact identifier application number: M017 JenGufun LIDOCAINE Pain Relief Gel-Patch LIDOCAINE PAIN RELIEF GEL-PATCH Henan Kangdi Medical Devices Co., Ltd. 51363a41-5dcc-6a3b-e063-6294a90a6c27 2026-05-07 Warnings Exact identifier application number: M017 Lidoxi LIDOCAINE T&T Pharma Holdings LLC 513c517e-c098-02aa-e063-6294a90ac8a4 2026-05-07 Warnings Exact identifier application number: M017 Harris Teeter Hydrocortisone HYDROCORTISONE HARRIS TEETER LLC 4e8199f8-96ec-5342-e063-6294a90afb2d 2026-05-07 Warnings Exact identifier application number: M017 CAREALL Hydrocortisone Maximum Strength HYDROCORTISONE New World Imports, Inc. 5114cdba-96a1-c399-e063-6294a90aac12 2026-05-06 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