Astonea Skin Protectant
- Product NDC
- 77338-050
- 11-digit product format
- 773380050
- Labeler code
- 77338
- Product ID
- 77338-050_1bbb3c29-f7ab-8b08-e063-6294a90a0129
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ZINC OXIDE
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- ASTONEA LABS PRIVATE LIMITED
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-11-21
- Substance
- ZINC OXIDE
- Active strength
- 18 mg/g
- Pharmacologic classes
- Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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 | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 77338-050-04 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 77338-050-04 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 77338-050-04 | 1332a3947898… | d4bfe170f9cd… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Astonea Skin Protectant
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ZINC OXIDE | 18 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| SOI2LOH54Z | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1044412 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| e3c7a515-3e77-da85-e053-2995a90a3ee1 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 60c52429-fcef-eb54-2387-43bc9e4f296b | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 77338-050-04 | 2024-06-25 | C162847 | 48780-1 | 1030e365-1d76-111a-e063-dadaa90a10e2 | Astonea skin protectant 1.8% ZNO |
| 77338-050-04 | 2024-01-30 | C162847 | 48780-1 | 1030e365-1d76-111a-e063-dadaa90a10e2 | Astonea skin protectant 1.8% ZNO |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 77338-050-04 | Astonea Skin Protectant | 113 g in 1 TUBE | OINTMENT | 113 | 3 |
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 |
|---|---|---|---|---|
| 1044412 | zinc oxide 1.8 % Topical Ointment | PSN | e3c7a515-3e77-da85-e053-2995a90a3ee1 | 3 |
| 1044412 | zinc oxide 0.018 MG/MG Topical Ointment | SCD | e3c7a515-3e77-da85-e053-2995a90a3ee1 | 3 |
| 1044412 | zinc oxide 1.8 % Topical Ointment | SY | e3c7a515-3e77-da85-e053-2995a90a3ee1 | 3 |
| 1044412 | ZNO 0.018 MG/MG Topical Ointment | SY | e3c7a515-3e77-da85-e053-2995a90a3ee1 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 77338-050-04 | 77338005004 | 113 g in 1 TUBE (77338-050-04) | 113 g | 2022-08-17 | 0000-00-00 | No | No | Current |