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
- 2026-12-31
- 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… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Astonea Skin Protectant
- Listing expiration
- 2026-12-31
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 |
|---|---|---|---|---|---|---|
| Dermaka Infants and Kids Multi Purpose Skin Protectant | ZINC OXIDE | Dermaka Skin Products LLC | f84dfd55-db6c-4d75-be67-4d13a139e209 | 2026-09-10 | Warnings | M016 |
| La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic Multipurpose | DIMETHICONE | L'Oreal USA Products Inc | 805cd262-2689-4818-8fed-ddefacbdde23 | 2026-09-10 | Warnings | M016 |
| La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Therapeutic Multipurpose | DIMETHICONE | Cosmetique Active Production | d19f482c-bec7-45aa-b22f-fe91a3dc717d | 2026-09-10 | Warnings | M016 |
| Zinc Oxide | ZINC OXIDE | CVS Pharmacy, Inc. | 35e67726-4527-4cd7-8e73-30325a32402c | 2026-09-09 | Warnings, Adverse reactions | M016 |
| Lanolin, Petrolatum | LANOLIN, PETROLATUM | CVS Pharmacy, Inc. | 606f65a8-08fd-4ab6-9d68-03ddf662bdf0 | 2026-09-09 | Warnings, Adverse reactions | M016 |
| Eczema Soothing Moisturizing Cream | COLLOIDAL OATMEAL | Nice-Pak Products, LLC | 23548524-2e2e-4d1a-9ebb-6f86d6279e93 | 2026-09-09 | Warnings, Adverse reactions | M016 |
| Advanced Healing | PETROLATUM | Walgreen Co. | 22bd8e87-965c-466b-bb9b-7d4753e500bc | 2026-09-09 | Warnings, Adverse reactions | M016 |
| Drs. pharmacy Scar Cream | ALLANTOIN | OL PHARMA TECH, LLC Drs PHARMACY | d0381034-8cf7-5e8d-e053-2995a90a9faa | 2026-09-09 | Warnings | M016 |
| Drs. Pharmacy baby healing | PETROLATUM | OL PHARMA TECH, LLC Drs PHARMACY | 5b14ffa0-9486-a7fe-e063-6394a90ab3ed | 2026-09-09 | Warnings | M016 |
| Wart Remover | GLYCERIN | Shantou Ouhoe Technology Co., Ltd. | 5af3afe1-dad5-91b7-e063-6294a90ab95e | 2026-09-08 | Warnings | M016 |
| Medline | DIMETHICONE | Medline Industries, LP | 5afb3595-f014-153e-e063-6294a90ad34b | 2026-09-08 | Warnings | M016 |
| Medline | DIMETHICONE | Medline Industries, LP | 5afb59b4-491c-45bb-e063-6294a90a0ae6 | 2026-09-08 | Warnings | M016 |
| Claravie | ALUMINUM HYDROXIDE GEL | Gentell LLC | 5afea757-8feb-f907-e063-6394a90a6259 | 2026-09-08 | Warnings | M016 |
| Clear Anti Itch | PRAMOXINE HCL, ZINC ACETATE | United Natural Foods, Inc. dba UNFI | 242adc68-f9e0-4f69-a580-a107d1634b50 | 2026-09-04 | Warnings, Adverse reactions | M016 |
| Calamine | CALAMINE, PRAMOXINE HCL | United Natural Foods, Inc. dba UNFI | 0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea | 2026-09-04 | Warnings, Adverse reactions | M016 |
| FIRST AID BEAUTY FAB ULTRA REPAIR SKIN PROTECTANT Kit | COLLOIDAL OATMEAL | The Procter & Gamble Manufacturing Company | 5a9aaca8-474a-0393-e063-6394a90a5a3a | 2026-09-04 | Warnings | M016 |
| Aveeno Eczema Therapy Cream | COLLOIDAL OATMEAL | Kenvue Brands LLC | 5a7b0470-3ed5-5b92-e063-6294a90ae0f4 | 2026-09-03 | Warnings | M016 |
| First Aid Beauty Face and Body Bestsellers Kit | COLLOIDAL OATMEAL | The Procter & Gamble Manufacturing Company | 5a974dbf-84ac-5374-e063-6294a90a8da0 | 2026-09-03 | Warnings | M016 |
| Pure Petrolatum Jelly | PETROLATUM | Jell Pharmaceuticals Pvt. Ltd. | cdc297cb-476a-6da9-e053-2a95a90a399a | 2026-09-02 | Warnings | M016 |
| Nail Treatment Liquid | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 5a7cd607-a50e-17d0-e063-6294a90acdb2 | 2026-09-02 | 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 |