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 | 2026-10-15 | ||
| excluded package | package | 50157-477 | 50157-477-18 | I | Inactivated by FDA | 2026-10-15 |
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 |
|---|---|---|---|---|---|---|
| Daily Moisturizing | DIMETHICONE | Aldi, Inc | 118a1a07-7283-4353-97b5-6ac3b1cc1430 | 2026-05-08 | Warnings, Adverse reactions | M016 |
| Dove | ANTIBACTERIAL CARE MOISTURIZING CREAM | Conopco Inc. d/b/a/ Unilever | 5150f48c-ff0c-ce39-e063-6394a90ad424 | 2026-05-08 | Warnings | M016 |
| Seedlings Diaper Rash Cream | ZINC OXIDE | Young Living Essential Oils, LC. | 4d8aeaba-ddb1-6f74-e054-00144ff88e88 | 2026-05-08 | Warnings | M016 |
| Nail Repairs Patches | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 5120b708-047a-1182-e063-6394a90a74c3 | 2026-05-06 | Warnings | M016 |
| AOAO Acne Buster Salicylic Acid Drying Serum | ZINC OXIDE,NIACINAMIDE,COLLOIDAL SULFUR,AZELAIC ACID,SALICYLIC ACID. | Guangzhou Senmai Biotechnology Co.,Ltd. | 512185a5-5c1d-ef9f-e063-6394a90a81af | 2026-05-06 | Warnings | M016 |
| AKOLKOL TOENAIL FUNGUS TREATMENT | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 5121c341-e5e9-2b36-e063-6394a90a93b8 | 2026-05-06 | Warnings | M016 |
| Beyond Good Diaper Rash | ZINC OXIDE | Babylist, Inc | 512b62df-4f08-d839-e063-6294a90ab52f | 2026-05-06 | Warnings | M016 |
| Acne Buster Salicylic Acid Drying Serum | ZINC OXIDE,NIACINAMIDE,COLLOIDAL SULFUR,AZELAIC ACID,SALICYLIC ACID. | Guangzhou Senmai Biotechnology Co.,Ltd. | 4c531280-bc5b-1cf2-e063-6394a90a034a | 2026-05-05 | Warnings | M016 |
| PEGO Acne Buster Salicylic Acid Drying Serum | ZINC OXIDE,NIACINAMIDE,COLLOIDAL SULFUR,AZELAIC ACID,SALICYLIC ACID. | Guangzhou Senmai Biotechnology Co.,Ltd. | 511eaced-c4d8-ae94-e063-6394a90a320e | 2026-05-05 | Warnings | M016 |
| Rugby Gas relief | SIMETHICONE | Rugby Laboratories | 9b84f74f-8609-489d-b411-3103afa1b5c2 | 2026-05-04 | Warnings | M016 |
| Vitamin A and D | PETROLATUM | Aldermed Inc. | 3f13a15c-8b64-48f0-a459-853b9097bc31 | 2026-05-04 | Warnings | M016 |
| Zinc Oxide Skin Protectant | ZINC OXIDE 20% | Aldermed Inc. | a55ac5b4-bac7-4d2a-8ac8-c3eaf7e89e52 | 2026-05-04 | Warnings | M016 |
| Petroleum Jelly | WHITE PETROLATUM | Aldermed Inc. | 4e02af41-db86-46d8-a97d-332d84eced6f | 2026-05-04 | Warnings | M016 |
| Daily Moisturizer | LOTION | Walgreens | fc65f673-b23d-1ffa-e053-6394a90a0966 | 2026-05-03 | Warnings | M016 |
| Dry Skin Healing | PETROLATUM | Walgreen | 0397507d-4b6e-c679-e063-6294a90a0b33 | 2026-05-03 | Warnings | M016 |
| Daily Moisturizer | LOTION | Walgreen | fc67037a-ed31-f678-e053-6394a90a7175 | 2026-05-03 | Warnings | M016 |
| Skin Relief | LOTION | Walgreen | fc678e80-e63d-e3fe-e053-6394a90aa7d6 | 2026-05-03 | Warnings | M016 |
| Petroleum Jelly | WHITE PETROLATUM | Walmart INC | f76ceecc-ef11-3839-e053-6394a90a8d4a | 2026-05-03 | Warnings | M016 |
| Herpecin L | DIMETHICONE AND MERADIMATE AND OCTINOXATE AND OCTISALATE AND OXYBENZONE | Focus Consumer Healthcare, LLC | 5b6ed4e9-3e69-c773-e053-2991aa0a7dfe | 2026-05-01 | Warnings | M016 |
| Calamine | FERRIC OXIDE RED | Retail Business Services, LLC | 7291e175-a9b6-4c47-93ce-227ce11e4599 | 2026-04-30 | Warnings, Adverse reactions | 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 |