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 |
|---|---|---|---|---|---|---|
| Petroleum | WHITE PETROLATUM | Harris Teeter | de380df6-cc6e-4b2a-98de-fc08eeb6e8ea | 2026-02-04 | Warnings, Adverse reactions | M016 |
| Petroleum | WHITE PETROLATUM | Hy-Vee, Inc. | 45867f42-9562-c111-e063-6394a90adb70 | 2026-02-04 | Warnings, Adverse reactions | M016 |
| Daily Moisturizing | DIMETHICONE | Lidl US, LLC | c82f236d-c27f-458c-bcd8-19877d09e9a3 | 2026-02-04 | Warnings, Adverse reactions | M016 |
| Daily Moisturizing | DIMETHICONE | Lidl US, LLC | 5e83811f-773f-43e7-bab8-f9e558fb0e00 | 2026-02-04 | Warnings, Adverse reactions | M016 |
| Calamine | FERRIC OXIDE RED | Major Pharmaceuticals | c25be68d-834a-4959-8d47-01ec789406ba | 2026-02-04 | Warnings, Adverse reactions | M016 |
| Petroleum Skin Protectant | WHITE PETROLATUM | Major Pharmaceuticals | 0e7e11c5-a1f8-43c4-b8a6-211491052404 | 2026-02-04 | Warnings, Adverse reactions | M016 |
| Witch Hazel | WITCH HAZEL | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | d76e116f-4b22-4633-8487-17ad3b5778c7 | 2026-02-04 | Warnings | M016 |
| Comforts Petroleum Jelly | WHITE PETROLATUM | KROGER | 3feb3638-1cdc-62d4-e063-6294a90a1d89 | 2026-02-03 | Warnings | M016 |
| Daily Moisturizing | DIMETHICONE | CVS Pharmacy, Inc. | edc20df4-561e-486f-b9f1-900672a0f2a4 | 2026-02-03 | Warnings, Adverse reactions | M016 |
| Colloidal oatmeal | COLLOIDAL OATMEAL | CVS Pharmacy, Inc. | a153842c-d9ce-4658-912b-362a6f20b0aa | 2026-02-03 | Warnings, Adverse reactions | M016 |
| Petroleum Skin Protectant | WHITE PETROLATUM | Demoulas Super Markets, Inc | 702215f0-4cfd-4a23-b47a-da691c136634 | 2026-02-03 | Warnings, Adverse reactions | M016 |
| Neurexa | COLLOIDAL OATMEAL | METHODIQ INC. | 494d7915-acad-260e-e063-6394a90a182c | 2026-02-03 | Warnings | M016 |
| Thera Plus Vitamin A and D Cream | DIMETHICONE, ZINC OXIDE | FOURSTAR GROUP USA, INC. | 36f09fa4-a3b8-4104-9745-ee60aa493b06 | 2026-02-02 | Warnings | M016 |
| Vitamin A D | LANOLIN, PETROLATUM | Kroger Co. | b4aa9b58-d95e-4dac-9a34-213482e8ca34 | 2026-02-02 | Warnings, Adverse reactions | M016 |
| Nail Nourishing Pen | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 49e45462-a05f-d370-e063-6394a90a1e0f | 2026-02-02 | Warnings | M016 |
| Barrier Repair Cream | CREAM | Steel City Health Private Limited | 4842f653-7137-eca4-e063-6394a90a8c55 | 2026-01-31 | Warnings | M016 |
| Cracked Heel Repair Balm | DIMETHICONE | Delta Brands Inc. | 42b7c9f8-0557-8e33-e063-6394a90a5919 | 2026-01-30 | Warnings | M016 |
| Readybath TPC Total Perineal Care | DIMETHICONE | Medline Industries, Inc. | 43a3f0f7-f76f-434d-a21f-7eaa3638913d | 2026-01-30 | Warnings | M016 |
| Lanolin, Petrolatum | LANOLIN, PETROLATUM | Rite Aid Corporation | 1b6d7cdf-e7bc-4fd4-939c-5eb0eaa1744d | 2026-01-30 | Warnings, Adverse reactions | M016 |
| Zinc Oxide | ZINC OXIDE | Rite Aid Corporation | 3af9f0e5-0d79-4178-b29e-3b60735bf4ce | 2026-01-30 | Warnings, Adverse reactions | 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 |