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 |
|---|---|---|---|---|---|---|
| DawnMist White Petrolatum | WHITE PETROLATUM | Dukal LLC | 598e9d46-6450-af60-e063-6394a90a3a6b | 2026-08-21 | Warnings | M016 |
| MUSTELA Diaper Rash 1 2 3 | ZINC OXIDE | Expanscience Laboratories d/b/a Mustela | 163f388e-849d-4b7e-93c1-9045d77a9ec2 | 2026-08-21 | Warnings | M016 |
| Medline | WHITE PETROLATUM, ZINC OXIDE | Medline Industries, LP | 0073de92-585d-e01a-e063-6394a90a2ec2 | 2026-08-21 | Warnings | M016 |
| Mederma PM | DIMETHICONE | L Perrigo Company | 8c728904-28f4-4333-a9ea-20996fd1b007 | 2026-08-21 | Warnings | M016 |
| Earths Care Hemorrhoid Relief | WITCH HAZEL AND MENTHOL, UNSPECIFIED FORM | DLC Laboratories, Inc. | e860d65b-126d-4d77-8003-9d1381849ab5 | 2026-08-20 | Warnings | M016 |
| ClaraVie | PETROLATUM | Gentell LLC | 596987e4-4205-b911-e063-6294a90aa570 | 2026-08-19 | Warnings | M016 |
| ClaraVie | ZINC OXIDE | Gentell LLC | 596abd98-17d7-2a22-e063-6294a90af57d | 2026-08-19 | Warnings | M016 |
| Claravie Skin Repair Cream | DIMETHICONE | Gentell LLC | 596ae269-172e-aef5-e063-6394a90a4e2a | 2026-08-19 | Warnings | M016 |
| Claravie | LANOLIN | Gentell LLC | 596c1b73-e34d-c97d-e063-6394a90ada1b | 2026-08-19 | Warnings | M016 |
| ClaraVie | MENTHOL, ZINC OXIDE | Gentell LLC | 596c467f-a056-ea78-e063-6394a90a79f2 | 2026-08-19 | Warnings | M016 |
| ClaraVie | LANOLIN | Gentell LLC | 596fe32d-be34-0635-e063-6394a90a2fc0 | 2026-08-19 | Warnings | M016 |
| Medpride | ZINC OXIDE | Shield Line LLC | e2689cae-e347-4c0b-825b-6281a0b7c2f1 | 2026-08-18 | Warnings | M016 |
| Eczema Skin Relief Cream | COLLOIDAL OATMEAL | CVS Health | 98fac854-f7b0-4c6e-888d-1bdc6b9323b9 | 2026-08-17 | Warnings | M016 |
| Zinc Oxide | ZINC OXIDE | ADUSA Distribution, LLC | 5940399c-31e3-6d51-e063-6294a90a8e7c | 2026-08-17 | Warnings, Adverse reactions | M016 |
| Intimate CareGel | HYALURONIC ACID | Guangzhou Yilong Cosmetics.,Ltd | 5918d204-52db-e6d0-e063-6394a90ab78c | 2026-08-14 | Warnings | M016 |
| TENA Proskin protective cream | ZINC OXIDE | Essity HMS North America Inc. | b840377f-a297-4aff-900e-7ea8b7c98717 | 2026-08-13 | Warnings, Adverse reactions | M016 |
| Medline | WHITE PETROLATUM, ZINC OXIDE | Medline Industries, LP | 087d66ff-1a8c-dcb2-e063-6294a90a2f8c | 2026-08-11 | Warnings | M016 |
| Nail Renewal Liquid | GLYCERIN | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 581f7192-fc17-a706-e063-6394a90a3ffa | 2026-08-11 | Warnings | M016 |
| Intertrigo Relief Cream | GLYCERIN | Shantou South Moon Biotechnology Co., Ltd. | 587220c9-0ae9-3438-e063-6394a90a0a86 | 2026-08-07 | Warnings | M016 |
| Calamine | FERRIC OXIDE RED | The Kroger Co. | 9ddcd6ba-1aed-48f8-a91a-54bd6f0d9308 | 2026-08-06 | 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 |