Home NDC 0904-5354 Banophen
Product NDC 0904-5354
11-digit product format 009045354
Labeler code 0904
Product ID 0904-5354_9d9d4074-238a-49d0-a5ef-39414da07434
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine Hydrochloride, Zinc Acetate
Dosage form CREAM
Route TOPICAL
Labeler Major Pharmaceuticals
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2009-06-19
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 Banophen
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1087026 Internal RxNorm lookup 1092428 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 0904-5354-31 Banophen 1 in 1 CARTON CREAM 1 5 0904-5354-31 Banophen 28 g in 1 TUBE CREAM 28 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PHYSICIANS TOTAL CARE, INC.] 1 DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 BANOPHEN (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [MAJOR PHARMACEUTICALS] 1 ZINC ACETATE ACTIVE INGREDIENT FM5526K07A DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PHYSICIANS TOTAL CARE, INC.] 1 ZINC ACETATE ACTIVE INGREDIENT FM5526K07A BANOPHEN (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [MAJOR PHARMACEUTICALS] 1 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PHYSICIANS TOTAL CARE, INC.] 1 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M BANOPHEN (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [MAJOR PHARMACEUTICALS] 1 ZINC ACTIVE MOIETY J41CSQ7QDS DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PHYSICIANS TOTAL CARE, INC.] 1 ZINC ACTIVE MOIETY J41CSQ7QDS BANOPHEN (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [MAJOR PHARMACEUTICALS] 1 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PHYSICIANS TOTAL CARE, INC.] 1 DIAZOLIDINYL UREA INACTIVE INGREDIENT H5RIZ3MPW4 DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PHYSICIANS TOTAL CARE, INC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PHYSICIANS TOTAL CARE, INC.] 1 PEG-2 STEARATE INACTIVE INGREDIENT 94YQ11Y95F DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PHYSICIANS TOTAL CARE, INC.] 1 PEG-20 STEARATE INACTIVE INGREDIENT NBX892EA57 DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PHYSICIANS TOTAL CARE, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PHYSICIANS TOTAL CARE, INC.] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PHYSICIANS TOTAL CARE, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PHYSICIANS TOTAL CARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-5354 BANOPHEN (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [MAJOR PHARMACEUTICALS] 4 Current NDC, Legacy NDC, 2 package rows 20240926_9758d886-bd58-4eb2-a827-fa8e7fee2b7c.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 18 of 152 · 3,029 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 0904-5354-31 00904535431 1 TUBE in 1 CARTON (0904-5354-31) / 28 g in 1 TUBE 1 tube 2009-06-19 0000-00-00 No No Current