Home NDC 77338-164-01 Diaper Rash Cream 40% ZINC
Product NDC 77338-164
Requested package NDC 77338-164-01
11-digit product format 773380164
Labeler code 77338
Product ID 77338-164_16da8bcf-3e86-f435-e063-6294a90a7c8c
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler ASTONEA LABS PRIVATE LIMITED
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-03-06
Substance ZINC OXIDE
Active strength 40 g/100g
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 Diaper Rash Cream 40% ZINC
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 40 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1305337 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 77338-164-01 Diaper Rash Cream 40% ZINC 57 g in 1 TUBE CREAM 57 1 77338-164-01 Diaper Rash Cream 40% ZINC 1 in 1 BOX CREAM 1 1 77338-164-02 Diaper Rash Cream 40% ZINC 71 g in 1 TUBE CREAM 71 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 77338-164 DIAPER RASH CREAM 40% ZINC (ZINC OXIDE) CREAM [ASTONEA LABS PRIVATE LIMITED] 1 Current NDC, 3 package rows 20240426_16da985a-6210-ec82-e063-6294a90a132d.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 41 of 68 · 1,346 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Exemax Cream DIMETHICONE, ALLANTOIN PureTek Corporation 38e79055-df84-d314-e063-6394a90ac95f 2025-07-01 Warnings Exact identifier application number: M016 Procure Dimethicone 5% DIMETHICONE Twin Med LLC 38a7e4af-997d-549e-e063-6394a90a0bd6 2025-06-28 Warnings Exact identifier application number: M016 Zinc Oxide ZINC OXIDE OINTMENT Derma Sciences Canada Inc. 37eff762-1ea9-ec66-e063-6394a90a3d10 2025-06-19 Warnings Exact identifier application number: M016 Dr.Johnes SKIN TAG REMOVER SALICYLIC ACID Dr.Johnes LLC b731c55e-31ee-429f-8432-fac7c5718d83 2025-06-18 Warnings Exact identifier application number: M016 Dr. Johne SKIN TAG REMOVER SALICYLIC ACID Dr.Johnes LLC 6c5adc3c-9d45-449a-ad42-f9571851cd18 2025-06-18 Warnings Exact identifier application number: M016 THERAPLEX Eczema Therapy Moisturizing Skin Protectant with Colloidal Oatmeal OATMEAL THERAPLEX, LLC e51aa467-ffe7-4c6b-8588-6df8592596d4 2025-06-16 Warnings Exact identifier application number: M016 ZIIDII Wild Yam Cream WILD YAM Guangzhou Haishi Biological Technology Co., Ltd. 3733154a-4884-9988-e063-6294a90aa78c 2025-06-10 Warnings Exact identifier application number: M016 Aveeno Calm Plus Restore Skin Therapy Balm COLLOIDAL OATMEAL Kenvue Brands LLC dbe7a2cc-9c21-2a48-e053-2a95a90a54e2 2025-06-04 Warnings Exact identifier application number: M016 Petroleum Jelly WHITE PETROLATUM WALGREENS 2017113f-d192-5fbb-e063-6294a90a83b0 2025-05-31 Warnings Exact identifier application number: M016 AHHH Bite Relief SODIUM BICARBONATE 78271 25a1e070-9228-4ec9-e063-6294a90ad78d 2025-05-27 Warnings Exact identifier application number: M016 SupreH Bee Venom Skin Tag Treatment Liquid SUPREH BEE VENOM SKIN TAG REMOVER LIQUID Shenzhen Xinxin Yunhai Technology Co., Ltd. 35ca9836-917a-b0ac-e063-6294a90a28a2 2025-05-23 Warnings Exact identifier application number: M016 terrasil Diabetics Ulcer and Bed Sore Relief ALLANTOIN Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions 35d2738c-dacf-7309-e063-6294a90aab4c 2025-05-23 Warnings Exact identifier application number: M016 terrasil Diabetics Ulcer and Sore Relief ALLANTOIN Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions fd6bf169-f1e2-48d4-b98d-8f3c39981a89 2025-05-23 Warnings Exact identifier application number: M016 Perfect 10 Soothing Recovery PETROLATUM Topiderm, Inc. e3a4f038-d084-4d77-bd35-13f41856a615 2025-04-30 Warnings Exact identifier application number: M016 Diabetic Advanced Healing Cream DIMETHICONE Neoteric Cosmetics, Inc. 46996845-9398-41d8-bf99-79f6a29bec28 2025-04-30 Warnings Exact identifier application number: M016 BabyDiaperCream BABY DIAPER CREAM Whole Foods Market d7b19529-d0b2-638b-e053-2a95a90acf2f 2025-04-29 Warnings Exact identifier application number: M016 ChapIce Moisture SPF 15 Lip Balm OXYBENZONE, OCTINOXATE, PETROLATUM Navajo Manufacturing Company Inc. 60ce1a8c-180a-161e-e053-2991aa0ae981 2025-04-29 Warnings Exact identifier application number: M016 Assurance Barrier Cream DIMETHICONE CREAM Walmart Inc 23a2a04f-71ce-4fa1-e063-6394a90a649e 2025-04-22 Warnings Exact identifier application number: M016 Aveeno Baby Eczema Therapy Moisturizing OATMEAL Kenvue Brands LLC 21d2c0a0-70c3-7fd3-e063-6394a90a46d4 2025-04-18 Warnings Exact identifier application number: M016 Secura Extra Protective ZINC OXIDE Smith & Nephew Medical Ltd 499a1944-1682-4798-9058-3748a5eaa420 2025-04-17 Warnings Exact identifier application number: M016
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 77338-164-01 77338016401 1 TUBE in 1 BOX (77338-164-01) / 57 g in 1 TUBE 1 tube 2024-03-06 No No Current