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 |
|---|---|---|---|---|---|---|
| Clear Anti-Itch | PRAMOXINE HCL, ZINC ACETATE | Old East Main Co. | 91df1434-bce6-4c6e-beee-cb5ec1cc8fff | 2026-03-02 | Warnings, Adverse reactions | M016 |
| Advanced Healing | PETROLATUM | Old East Main Co. | cf916191-1de2-4305-b783-9e074c1ad94b | 2026-03-02 | Warnings, Adverse reactions | M016 |
| Eczema Relief | COLLOIDAL OATMEAL | Old East Main Co. | b2dba027-c295-4a41-8d30-144904e1aa34 | 2026-03-02 | Warnings, Adverse reactions | M016 |
| Baby Eczema Therapy | COLLOIDAL OATMEAL | Old East Main Co. | 9720e2ad-1bcf-4023-8e92-22a962df3aad | 2026-03-02 | Warnings, Adverse reactions | M016 |
| Calamine | FERRIC OXIDE RED | Chain Drug Marketing Association | 86ff4875-9007-4b7b-8f46-16cbd475d4bb | 2026-02-27 | Warnings, Adverse reactions | M016 |
| Clear Anti-Itch | PRAMOXINE HCL, ZINC ACETATE | Chain Drug Marketing Association | 1ff6bd85-3658-47ea-b6ca-0eb5d8dbb693 | 2026-02-27 | Warnings, Adverse reactions | M016 |
| Calamine | CALAMINE, PRAMOXINE HCL | Chain Drug Marketing Association | 6c848b98-f01c-40f2-a9aa-2af76cb370c8 | 2026-02-27 | Warnings, Adverse reactions | M016 |
| Diaper Rash | ZINC OXIDE | The Kroger Co. | fcffbe1f-79b8-451a-9384-19533b81d8c8 | 2026-02-27 | Warnings, Adverse reactions | M016 |
| Petroleum | WHITE PETROLATUM | The Kroger Co. | d2095c7b-61ca-40d3-bbf1-04bed4dd789c | 2026-02-27 | Warnings, Adverse reactions | M016 |
| Daily Moisturizing | DIMETHICONE | The Kroger Co. | ea8b186c-82d5-4552-bcce-03e56023ea99 | 2026-02-27 | Warnings, Adverse reactions | M016 |
| Diaper Rash Cream | ZINC OXIDE | Smalls Brand LLC DBA Roe Wellness | 4bd29285-29b4-5d57-e063-6294a90af481 | 2026-02-27 | Warnings | M016 |
| Vitamin A D | LANOLIN, PETROLATUM | Walmart Inc. | 5893801a-25e1-4750-a55b-d9cddd3f1284 | 2026-02-27 | Warnings, Adverse reactions | M016 |
| Diaper Rash | ZINC OXIDE | Walmart Inc. | 320bcbd3-9e91-437f-99c5-066f880a4b32 | 2026-02-27 | Warnings, Adverse reactions | M016 |
| Skin Protectant | PETROLATUM | Walmart Inc. | eb836922-f467-42ab-a6e7-b787d97e6c17 | 2026-02-27 | Warnings, Adverse reactions | M016 |
| Advanced Healing | PETROLATUM | Walmart Inc. | aa7dbf7f-50be-475b-8140-68be3fa93507 | 2026-02-27 | Warnings, Adverse reactions | M016 |
| White Petrolatum | WHITE PETROLATUM | Walmart Inc. | 176d7711-7c4f-4319-91af-0aba1260c412 | 2026-02-27 | Warnings, Adverse reactions | M016 |
| Soothing Moisturizing | COLLOIDAL OATMEAL | Walmart Inc. | 2d813455-c268-4c6d-9952-eaf0e0007d90 | 2026-02-27 | Warnings, Adverse reactions | M016 |
| Rapid Repair Healing Cream | ALLANTOIN, DIMETHICONE | June Jacobs Labs LLC | 186c13be-5e41-b9c9-e063-6294a90ad574 | 2026-02-26 | Warnings | M016 |
| Lanashield | LANOLIN | Dynarex Corporation | 94b277dc-6512-4d36-8485-8ea510097428 | 2026-02-26 | Warnings | M016 |
| GLADSKIN ECZEMACT ECZEMA | COLLOIDAL OATMEAL | Micreos North America, Inc. | 06f9af75-c5ff-d37b-e063-6394a90a4f6c | 2026-02-25 | 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 |