Zinc Oxide 40%
- Product NDC
- 50157-477
- 11-digit product format
- 501570477
- Labeler code
- 50157
- Product ID
- 50157-477_e91ff69e-84b8-ead0-e053-2995a90a752d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diaper Rash Skin
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- BRANDS INTERNATIONAL
- Application
- M016
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2022-09-20
- Marketing end
- 0000-00-00
- Substance
- ZINC OXIDE
- Active strength
- 40 g/100mL
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 50157-477 | I | Inactivated by FDA | 2026-10-12 | ||
| excluded package | package | 50157-477 | 50157-477-18 | I | Inactivated by FDA | 2026-10-12 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50157-477-18 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 50157-477-18 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 50157-477-18 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 50157-477-18 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 50157-477-18 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 50157-477-18 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 50157-477-18 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 50157-477-18 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 50157-477-18 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50157-477-18 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-8e40-d83d-e063-dadaa90ab31f | Zinc Oxide 40% Diaper Rash Cream |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50157-477-18 | Zinc Oxide 40% | 118 mL in 1 TUBE | CREAM | 118 | 1 |
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Zinc Oxide 20% | ZINC OXIDE | Trifecta Pharmaceuticals USA | 8cbe9b1f-fec0-9579-e053-2995a90ac461 | 2026-06-22 | Warnings | M016 |
| Petroleum Skin Protectant | WHITE PETROLATUM | Walmart Inc. | e294a871-ae73-4a4f-89a3-9ebf0b4fd03a | 2026-06-19 | Warnings, Adverse reactions | M016 |
| Diaper Rash Cream | ZINC OXIDE | Foshan Desha Biotechnology Co., Ltd. | 5487ad62-3d73-042e-e063-6394a90afe8c | 2026-06-18 | Warnings | M016 |
| Baby HealingOintment | PETROLATUM | Foshan Desha Biotechnology Co., Ltd. | 5488b81a-e5fe-1452-e063-6394a90a2ae4 | 2026-06-18 | Warnings | M016 |
| Baby Eczema Moisturizing Cream | COLLOIDAL OATMEAL | Foshan Desha Biotechnology Co., Ltd. | 548a0c34-6aac-14f7-e063-6394a90ae652 | 2026-06-18 | Warnings | M016 |
| Jell with Vitamin A D | LANOLIN, PETROLATUM | Jell Pharmaceuticals Pvt Ltd. | d976e5f0-1be5-d9c4-e053-2a95a90a44a4 | 2026-06-17 | Warnings | M016 |
| Dove | ANTIBACTERIAL CARE BEAUTY BAR | Conopco d/b/a Unilever | 547472cf-4902-584e-e063-6294a90a28ac | 2026-06-17 | Warnings | M016 |
| Dr Sosnowskis Chafing Hero Severe Chafing Balm | LANOLIN | Herstat (USA) Inc. | 389041a8-7316-b38e-e063-6294a90a3e8e | 2026-06-17 | Warnings | M016 |
| Drs. Pharmacy Creamy Cocoa Butter Petroleum Jelly | WHITE PETROLATUM | OL PHARMA TECH, LLC Drs PHARMACY | 546749e3-70c5-10e8-e063-6294a90ad8c4 | 2026-06-16 | Warnings | M016 |
| Drs. Pharmacy Creamy Petroleum Jelly | WHITE PETROLATUM | OL PHARMA TECH, LLC Drs PHARMACY | 54698388-f9e8-c470-e063-6394a90a783b | 2026-06-16 | Warnings | M016 |
| Medline | ZINC OXIDE | Medline Industries, LP | 3c319953-04fc-87a8-e063-6294a90a5058 | 2026-06-15 | Warnings | M016 |
| Calamine, Pramoxind HCl | CALAMINE, PRAMOXIND HCL | H E B | 4a7a0b09-d9bc-e752-e063-6394a90a9f2c | 2026-06-15 | Warnings, Adverse reactions | M016 |
| Calamine, Zinc Oxide | CALAMINE, ZINC OXIDE | H E B | 4a79259e-64ac-d187-e063-6294a90a78db | 2026-06-15 | Warnings, Adverse reactions | M016 |
| HEALMUSZ HEALTHY FEET | UREA 40% SALICYLIC ACID 2% GREEN TEA LEAFL 1% COCONUT OIL 1% HEALTHY FEET | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a34b6de-03ec-3be4-e063-6294a90afb52 | 2026-06-14 | Warnings | M016 |
| PUVIDA SNOW BLEACH | NIACINAMIDE 15% SNOW BLEACH | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a48ebbd-7c80-1bce-e063-6294a90ab4ae | 2026-06-14 | Warnings | M016 |
| XIMONTH Foot Shoe Deodorizer | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 541d9ce9-62ad-847e-e063-6394a90a55e0 | 2026-06-13 | Warnings | M016 |
| Skin Protectant with 33% Petrolatum Advance Moisturizing Cream | PETROLATUM | Aldermed Inc. | 87413149-d39f-4f8a-b1c9-6de5eb37ff7e | 2026-06-12 | Warnings | M016 |
| Zinc Oxide 20% | ZINC OXIDE, WHITE PETROLATUM | Aldermed Inc. | 54154a72-27ad-7bfa-e063-6394a90a4eca | 2026-06-12 | Warnings | M016 |
| Circletong Tag Wart Remover Patches | GLYCERIN | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 541b0fe9-f900-8191-e063-6394a90af321 | 2026-06-12 | Warnings | M016 |
| Baby Butz | ZINC OXIDE | Olen Skin Care Corporation | e6be6b62-13a4-410d-b8ac-457b58fd23da | 2026-06-10 | Warnings | M016 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1305337 | zinc oxide 40 % Topical Cream | PSN | e9201a26-46b3-477f-e053-2995a90a5e0e | 1 |
| 1305337 | zinc oxide 400 MG/ML Topical Cream | SCD | e9201a26-46b3-477f-e053-2995a90a5e0e | 1 |
| 1305337 | zinc oxide 40 % Topical Cream | SY | e9201a26-46b3-477f-e053-2995a90a5e0e | 1 |
| 1305337 | ZNO 400 MG/ML Topical Cream | SY | e9201a26-46b3-477f-e053-2995a90a5e0e | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50157-477-18 | 50157047718 | 118 mL in 1 TUBE (50157-477-18) | 118 ml | 2022-09-20 | 0000-00-00 | No | No | Current |