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 148 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join EMU THERAPY Red Hot Pepper Pain Relief Cream MENTHOL, CAPSAICIN ACA MANAGEMENT LLC 36293885-b2dd-4fba-9748-35a3c9e05078 2023-11-06 Warnings Exact identifier application number: M017 ROPANA Pain Relief Cream HISTAMINE DIHYDROCHLORIDE FUSION PAIN SOLUTIONS LLC e0342aa3-ca80-40b7-bec6-1b33c4db398b 2023-11-06 Warnings Exact identifier application number: M017 EMU THERAPY Cool Menthol Therapy Pain Relief Cream MENTHOL ACA MANAGEMENT LLC 16894346-3513-41b1-b09f-72d84edcc4ac 2023-11-06 Warnings Exact identifier application number: M017 SKINS DELAY Climax Control Lidocaine LIDOCAINE HYDROCHLORIDE SKINS SEXUAL HEALTH LIMITED 0db91010-12f7-4f20-b96c-432915720d5a 2023-11-06 Warnings Exact identifier application number: M017 POWERECT Lidocaine Male Delay LIDOCAINE HYDROCHLORIDE SKINS SEXUAL HEALTH LIMITED 42e0c40f-1efd-45ef-815d-53d193d720eb 2023-11-06 Warnings Exact identifier application number: M017 ARTHRO LIFE Instant Pain Relief Cream MENTHOL BIOBEST SERVICES LLC 66eb1a78-6861-4693-b68e-bd4a664fc075 2023-11-06 Warnings Exact identifier application number: M017 PARACTIN QuantumActiv Pain Relief Cream MENTHOL NHR SCIENCE CORP ae2f89cf-120c-4c6f-9e81-4560e6fa0373 2023-11-06 Warnings Exact identifier application number: M017 FISICO Arthrozene Pain Cream MENTHOL FISICO INC. d02c4349-78dd-4672-9582-50124ea9f1e1 2023-11-06 Warnings Exact identifier application number: M017 BRONSON SOOTHE Pain Relief CAPSAICIN BRONSON NUTRITIONALS, LLC cedf8f43-b9a3-4a06-b3a1-cf82668541f8 2023-11-06 Warnings Exact identifier application number: M017 INTIMALE Benzocaine Delay Gel BENZOCAINE SKINS SEXUAL HEALTH LIMITED b845bfd5-ab73-495f-97ef-e959bc6311d9 2023-11-06 Warnings Exact identifier application number: M017 RAPID PAIN-RELIEF TOPICAL LIDOCAINE HYDROCHLORIDE, MENTHOL NORDIC HEALTHY LIVING INC. a06d6aca-9aa2-4bbe-bf77-4c85f1dd7870 2023-11-06 Warnings Exact identifier application number: M017 PURE PERSONAL All Natural Pain Relief Cream MENTHOL PURE PERSONAL CARE, LLC 8f3fb1d0-d238-4b4c-9816-7e335258d71d 2023-11-06 Warnings Exact identifier application number: M017 DIRT Pain Relieving Gel MENTHOL PURIVITAE, LLC 89c80a8f-227d-4ec0-9327-683892e73b6a 2023-11-06 Warnings Exact identifier application number: M017 DIRT Pain Relieving Gel MENTHOL PURIVITAE, LLC e43e2cbd-d114-4b11-8baf-7a775881cd97 2023-11-06 Warnings Exact identifier application number: M017 Celadrin Joint and Muscle Pain Relieving MENTHOL Factors Group of Nutritional Products 6396e4b6-2130-433b-bdb3-97c76dbe685c 2023-11-06 Warnings Exact identifier application number: M017 Atomic Balm METHYL SALICYLATE, CAPSAICIN The Hygenic Company, LLC d10028f3-ae6a-7b01-e053-2995a90a5a84 2023-11-05 Warnings Exact identifier application number: M017 HEMPCIN Advanced Topical Pain Relief Cream MENTHOL Pedicis Research, LLC 97f5e300-b780-4694-a681-60d5e0cfad65 2023-11-05 Warnings Exact identifier application number: M017 Point Relief cold Spot Pain Relieving roll-on MENTHOL Fabrication Enterprises 3f1db0ad-aaa8-4e14-9349-45057e0fb4a6 2023-11-05 Warnings Exact identifier application number: M017 LidoStat LIDOCAINE HCL Clinical Therapeutic Solutions 1825885b-9141-4515-bb69-a1c4a39fb10d 2023-11-05 Warnings Exact identifier application number: M017 Point Relief Cold Spot Pain Relieving MENTHOL Fabrication Enterprises 391af69f-74aa-48cf-bc96-75e5c4e0e445 2023-11-05 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