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 114 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Mentholatum Deep Heating Rub Extra Strength MENTHOL, METHYL SALICYLATE The Mentholatum Company f5684158-0d83-4031-b493-5422ddc73e78 2024-12-13 Warnings Exact identifier application number: M017 Discount Drug Mart Anti-Itch CAMPHOR, MENTHOL Discount Drug Mart 87d379da-103a-c751-e053-2995a90a56de 2024-12-13 Warnings Exact identifier application number: M017 Audiologist Anti-itch HYDROCORTISONE OAKTREE PRODUCTS, INC. 853e078e-1e91-d55f-e053-2991aa0a6dcd 2024-12-13 Warnings Exact identifier application number: M017 CVS Anti itch HYDROCORTISONE CVS 884df604-711b-4a3d-e053-2995a90a3a04 2024-12-13 Warnings Exact identifier application number: M017 Dermoplast Pain Relieving BENZOCAINE AND LEVOMENTHOL Advantice Health, LLC 2347f0b8-d463-422d-8583-65624d9a1a91 2024-12-12 Warnings Exact identifier application number: M017 HealthWise Medicated Foot Powder MENTHOL Veridian Healthcare 2916a0c3-2d66-d079-e063-6394a90acd6b 2024-12-12 Warnings Exact identifier application number: M017 Ease Your Pain MENTHOL Proximity Capital Partners LLC dba Asutra 83366ae1-e1d9-2a30-e053-2a91aa0a1cc4 2024-12-12 Warnings Exact identifier application number: M017 Natural Seal Itch Relief for Kids LIDOCAINE Kericure Inc. 31cc0c95-5864-4737-b085-8f58e00f4f05 2024-12-12 Warnings Exact identifier application number: M017 Vagisil Anti-Itch Creme Maximum Strength Sensitive Skin Formula HYDROCORTISONE ACETATE Combe Incorporated 9b69fa24-02dd-43e4-a81f-9a37968d7099 2024-12-12 Warnings Exact identifier application number: M017 VAGISIL Anti-Itch Medicated Creme Maximum Strength BENZOCAINE AND RESORCINOL Combe Incorporated bb73ebd7-ceb0-4b54-9e8f-77486d9037fb 2024-12-12 Warnings Exact identifier application number: M017 VAGISIL Anti-Itch Creme Regular Strength BENZOCAINE AND RESORCINOL Combe Incorporated dd303ff8-0deb-4292-bfd8-5bda91f86d51 2024-12-12 Warnings Exact identifier application number: M017 VAGISIL Anti-Itch Medicated Wipes Maximum Strength PRAMOXINE HYDROCHLORIDE Combe Incorporated b848f53d-8aea-4efe-aa2c-009d5121fc33 2024-12-12 Warnings Exact identifier application number: M017 Walgreens Cool and Heat MENTHOL 16% Walgreens ce1585f4-ca65-8d0c-e053-2995a90a8e89 2024-12-11 Warnings Exact identifier application number: M017 Walgreens Cool n Heat LIDOCAINE 4% Walgreens ce1b21d6-7aa6-2b18-e053-2995a90a4c91 2024-12-11 Warnings Exact identifier application number: M017 Walgreens Pain Burn Itch Relief BENZOCAINE 20%, MENTHOL 0.5% Walgreens cc6e4b42-fdd8-6ff7-e053-2995a90a3d1d 2024-12-11 Warnings Exact identifier application number: M017 Pramoxine Itch relief PRAMOXINE HCL 1% CVS e947694c-c122-0291-e053-2995a90ac39a 2024-12-11 Warnings Exact identifier application number: M017 Arthritis Cream TROLAMINE SALICYLATE 10% CVS d1663f50-479b-4d55-e053-2995a90a223f 2024-12-11 Warnings Exact identifier application number: M017 CVS Pain Relief MENTHOL 4% CVS d1660d55-1ee0-7aa2-e053-2995a90a6579 2024-12-11 Warnings Exact identifier application number: M017 CVS Muscle Rub MENTHOL 10%, METHYL SALICYLATE 15% CVS Health c72c9a95-4226-6d69-e053-2a95a90a8e1c 2024-12-11 Warnings Exact identifier application number: M017 BENGAY ULTRA STRENGTH NON-GREASY CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE Kenvue Brands LLC 0a41ec65-bd0b-4fc6-807d-74f353341cc7 2024-12-11 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