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 |
|---|---|---|---|---|---|---|
| Cetaphil Soothing Gel Cream | ALLANTOIN | Galderma Laboratories, L.P. | bab404f0-2f7a-4bac-b053-cbdc81c029b5 | 2025-11-24 | Warnings | M016 |
| health beyond VITAMINS AD | PETROLATUM | Nantong Health & Beyond Hygienic Products Inc. | de87da51-cf92-402c-b60f-5f28d1724124 | 2025-11-23 | Warnings | M016 |
| Medline | WHITE PETROLATUM | Medline Industries, LP | 00766a7b-797e-dd15-e063-6394a90af9ac | 2025-11-20 | Warnings | M016 |
| Itch Eraser Sensitive | SODIUM BICARBONATE | Tender Corporation d/b/a Adventure Ready Brands | 2250525a-45c2-42ea-e063-6394a90ac001 | 2025-11-18 | Warnings | M016 |
| Moisture Barrier Cream | PETROLATUM, ZINC OXIDE | Derma Sciences Canada Inc. | 43e01e22-7872-8e24-e063-6394a90a17ef | 2025-11-18 | Warnings | M016 |
| terrasil Bed Sore and Pressure Sore Relief | ALLANTOIN | Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions | d0e4a492-f833-4e92-bd4a-b0a07ce9a69e | 2025-11-18 | Warnings | M016 |
| terrasil Foot Ulcer and Sore Relief | ALLANTOIN | Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions | 2776080b-3ddb-ad6c-e063-6394a90a93e0 | 2025-11-18 | Warnings | M016 |
| After Bite Kids | SODIUM BICARBONATE | Tender Corporation d/b/a Adventure Ready Brands | 226c1420-d771-204f-e063-6294a90af9f6 | 2025-11-18 | Warnings | M016 |
| Petroleum with Cocoa | WHITE PETROLATUM | QUALITY CHOICE (Chain Drug Marketing Association) | 280d4bdb-30d3-44f2-9159-3aa9a1de9a5f | 2025-11-17 | Warnings | M016 |
| After Bite X Tech | SODIUM BICARBONATE | Adventure Ready Brands | e9e49ab4-3e1f-9fd4-e053-2a95a90a775a | 2025-11-17 | Warnings | M016 |
| Diaper Rash skin protectant | LANOLIN AND PETROLATUM | Universal Distribution Centre LLC | 29b5475d-6085-cfe6-e063-6294a90a7e74 | 2025-11-17 | Warnings | M016 |
| DERMOGEN | ZINC OXIDE | KRAMER NOVIS | 38e02d1c-c143-4da6-ad32-a3ce2861aac5 | 2025-11-14 | Warnings | M016 |
| Welmedix HomeCare PRO Rapid Relief Rash Cream | PETROLATUM, ZINC OXIDE | Welmedix LLC | 4382a6b4-0b1f-0822-e063-6394a90adffc | 2025-11-14 | Warnings | M016 |
| Petroleum with Cocoa | WHITE PETROLATUM | QUALITY CHOICE (Chain Drug Marketing Association) | 086b6563-cb73-4874-aa42-028f5e81b60d | 2025-11-13 | Warnings | M016 |
| Welmedix HomeCare PRO Fragile Skin Protectant | PETROLATUM | Welmedix LLC | 43840785-3640-9813-e063-6394a90a7770 | 2025-11-13 | Warnings | M016 |
| Petroleum Jelly Baby Fresh Scent 3.53oz | PETROLATUM | Rejoice International Corp. | 1309926f-ecd9-635e-e063-6294a90aaab3 | 2025-11-11 | Warnings | M016 |
| Petroleum Jelly Fragrance Free 3.53oz | PETROLATUM | Rejoice International Corp. | 12f8d9cc-aa77-e034-e063-6394a90a94dd | 2025-11-11 | Warnings | M016 |
| Petroleum Jelly Cocoa Butter Scent 3.53oz | PETROLATUM | Rejoice International Corp. | 1309b15b-5236-6e9f-e063-6294a90afe11 | 2025-11-11 | Warnings | M016 |
| ODLUMIVIE Tremella Revitalizing Cleanser | TREMELLA FUCIFORMIS WHOLE | ODLUMIVIE | 435e4736-bcef-c227-e063-6394a90a53d5 | 2025-11-11 | Warnings | M016 |
| ODLUMIVIE Peptide CalmMist | PALMITOYL TRIPEPTIDE-8 | ODLUMIVIE | 435e6717-5fbf-5cb2-e063-6294a90a40d7 | 2025-11-11 | 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 |