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 | 2026-10-05 | ||
| excluded package | package | 50157-477 | 50157-477-18 | I | Inactivated by FDA | 2026-10-05 |
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 |
|---|---|---|---|---|---|---|
| Petroleum Skin Protectant | WHITE PETROLATUM | Your Military Exchanges | 1a0aed14-8606-4676-b4b5-23dd415d43ac | 2026-09-02 | Warnings, Adverse reactions | M016 |
| Aloetouch Protect Fragrance Free | DIMETHICONE | Medline Industries, LP | 81f0071b-2bf3-455b-9e5d-8f3ca20adcdf | 2026-09-01 | Warnings | M016 |
| PURE PETROLATUM | PETROLATUM | VASA COSMETICS PRIVATE LIMITED | 5a57b197-3e18-b3ab-e063-6394a90aed82 | 2026-08-31 | Warnings | M016 |
| HYDROPHOR | HYDROPHOR | Akron Pharma Inc. | e6099df7-d418-479a-9d2e-ced523585aed | 2026-08-28 | Warnings | M016 |
| Witch Hazel | WITCH HAZEL | United Natural Foods, Inc. dba UNFI | d2d1bd9e-7025-4151-95f2-a2f521dc2be8 | 2026-08-28 | Warnings, Adverse reactions | M016 |
| Daily Moisturizing | DIMETHICONE | Your Military Exchanges | e7af5488-1c49-41e9-9d8b-d519c6107699 | 2026-08-28 | Warnings, Adverse reactions | M016 |
| Calamine | FERRIC OXIDE RED | Your Military Exchanges | af95a66c-f063-4019-80c6-6f7dc4fee4d8 | 2026-08-28 | Warnings, Adverse reactions | M016 |
| Estriol Cream | ESTRIOL | Guangxi Keyun E-commerce Co., Ltd. | 4deadcb6-0d46-bdd7-e063-6294a90a26d7 | 2026-08-27 | Warnings | M016 |
| Medline | DIMETHICONE | Medline Industries, LP | 0d964138-f68d-dbf5-e063-6294a90a8320 | 2026-08-27 | Warnings | M016 |
| Gembooxt ECZEMA RELIEF Cream | HYDROCORTISONE | Guangdong Quadrant Ecological Technology Co., Ltd. | 46490d65-f789-eaa2-e063-6294a90a623b | 2026-08-27 | Warnings | M016 |
| Serawise Eczema Relief | OATMEAL | DrAnaMaria. Com LLC | f0681436-d140-4e02-afe4-5b16de07afcd | 2026-08-26 | Warnings | M016 |
| Hair Regrowth Foam | GLYCERIN | Shantou Ouhoe Technology Co., Ltd. | 59ef5953-e96f-5707-e063-6294a90a3094 | 2026-08-26 | Warnings | M016 |
| Growth Treatment | GLYCERIN | Shantou Ouhoe Technology Co., Ltd. | 59fe12eb-574f-a199-e063-6394a90abd06 | 2026-08-26 | Warnings | M016 |
| Acne Relief | SALICYLIC ACID,NIACINAMIDE,PANTHENOL. | Guangzhou Senmai Biotechnology Co.,Ltd. | 59db0143-de57-59d2-e063-6294a90a32a8 | 2026-08-25 | Warnings | M016 |
| Witch Hazel | WITCH HAZEL | Your Military Exchanges | 4079fd56-55f3-4e69-93e0-7590c07fb794 | 2026-08-25 | Warnings, Adverse reactions | M016 |
| Salicylic Acid Acne Gel Cleanser | SALICYLIC ACID,PANTHENOL | Guangzhou Senmai Biotechnology Co.,Ltd. | 59eb395b-493b-efc9-e063-6294a90aa891 | 2026-08-25 | Warnings | M016 |
| Claravie | DIMETHICONE | Gentell LLC | 59c6da39-b5f1-8253-e063-6394a90a0e8f | 2026-08-24 | Warnings | M016 |
| Medline | DIMETHICONE | Medline Industries, LP | 0d94fd18-a120-e171-e063-6394a90ae9c0 | 2026-08-24 | Warnings | M016 |
| MUSTELA Diaper Rash 1 2 3 | ZINC OXIDE | Expanscience Laboratories d/b/a Mustela | 59cf1d1e-e951-9d58-e063-6394a90af0f3 | 2026-08-24 | Warnings | M016 |
| Claravie | ZINC OXIDE, DIMETHICONE | Gentell LLC | 598a5c0b-1e2f-1335-e063-6394a90ac4f4 | 2026-08-21 | 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 |