Barrier Balm
- Product NDC
- 75523-200
- 11-digit product format
- 755230200
- Labeler code
- 75523
- Product ID
- 75523-200_ea608b09-a044-7457-e053-2995a90a48af
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Skin Protectant
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- PROJECT CHEMISTRY, INC.
- Application
- M016
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2022-10-19
- Marketing end
- 0000-00-00
- Substance
- ZINC OXIDE
- Active strength
- 15 g/100g
- 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 | 75523-200 | I | Inactivated by FDA | 2026-10-27 | ||
| excluded package | package | 75523-200 | 75523-200-02 | I | Inactivated by FDA | 2026-10-27 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 75523-200-02 | Barrier Balm | 57 g in 1 TUBE | OINTMENT | 57 | 2 |
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 |
|---|---|---|---|---|---|---|
| Sunmark Phenolated Calamine | CALAMINE AND ZINC OXIDE AND PHENOL | Strategic Sourcing Services LLC | 8e68efc4-4c95-41c0-9fed-32297b1b2edc | 2023-12-19 | Warnings | M016 |
| Calm and Heal Melting Balm | ALLANTOIN | The Honest Company, Inc. | b08a1bd6-986d-9520-e053-2995a90a865e | 2023-12-19 | Warnings | M016 |
| TopCare Calagesic | CALAMINE AND PRAMOXINE HYDROCHLORIDE LOTION | TOPCO ASSOCIATES LLC | 8dced3ea-147b-3d46-e053-2a95a90aa1c0 | 2023-12-18 | Warnings | M016 |
| TopCare Calamine | CALAMINE 8% AND ZINC OXIDE 8% LOTION | TOPCO ASSOCIATES LLC | 8dcf134e-0427-0c43-e053-2995a90a7c26 | 2023-12-18 | Warnings | M016 |
| HEB Calaclear | ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE | H E B | 5d576794-88d1-484a-e053-2991aa0aa479 | 2023-12-18 | Warnings | M016 |
| Publix Calamine Medicated | ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE | Publix | 5d6ba4cf-f2cb-0ecb-e053-2991aa0a5673 | 2023-12-18 | Warnings | M016 |
| TopCare Calaclear | PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTION | TOPCO ASSOCIATES LLC | 8dce8817-b905-4064-e053-2995a90a071e | 2023-12-18 | Warnings | M016 |
| Assured Calamine | CALAMINE 8% AND ZINC OXIDE 8% | Greenbriar International | 9d378cc5-9af0-1389-e053-2995a90a0b96 | 2023-12-18 | Warnings | M016 |
| HEB Calagesic | ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE | H E B | 5d579680-6bcb-1161-e053-2991aa0aead1 | 2023-12-18 | Warnings | M016 |
| Publix Clear Anti-Itch | ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE | Publix | 5d6b905f-ed30-1ab7-e053-2a91aa0a816b | 2023-12-18 | Warnings | M016 |
| Humco Calaclear | PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE | Humco Holding Group, Inc. | 5fca3a73-6d66-496b-bd33-6e044f9039bc | 2023-12-15 | Warnings | M016 |
| Calamine Phenolated Topical Suspension | CALAMINE AND ZINC OXIDE AND PHENOL | Humco Holding Group, Inc | a3816729-be2b-4b4f-a609-953576cd2e3b | 2023-12-15 | Warnings | M016 |
| Humco Mineral Oil Light | MINERAL OIL | Humco Holding Group, Inc. | 753f35c3-1420-4817-ba63-b737a9c99a1d | 2023-12-15 | Warnings | M016 |
| Humco Witch Hazel | WITCH HAZEL | Humco Holding Group, Inc. | 3cf07016-a129-49ca-8fad-b67dda5aa009 | 2023-12-15 | Warnings | M016 |
| Rite Aid Calamine | CALAMINE 8% AND ZINC OXIDE 8% | Rite Aid Corporation | 5df71189-9b36-9dee-e053-2a91aa0a9e49 | 2023-12-15 | Warnings | M016 |
| GNP Witch Hazel | WITCH HAZEL | Amerisource Bergen | 45ac839d-215d-4c5f-8ae5-5e111d170061 | 2023-12-14 | Warnings | M016 |
| La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 Skin Protectant | GLYCERIN | L'Oreal USA Products Inc | 32eaaaab-41bd-4efe-a71d-92e3a702c1e5 | 2023-12-11 | Warnings | M016 |
| La Roche Posay Laboratoire Dermatologique Lipikar Eczema Relief | OATMEAL | COSMETIQUE ACTIVE PRODUCTION | e555de17-9b42-4125-a17b-467bc1d179d7 | 2023-12-11 | Warnings | M016 |
| La Roche Posay Laboratoire Dermatologique Lipikar Eczema Soothing Relief | OATMEAL | L'Oreal USA Products Inc | f7b71606-0044-4729-82e8-4514331806a0 | 2023-12-11 | Warnings | M016 |
| La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 | GLYCERIN | Cosmetique Active Production | 01c8a0d5-bcd1-4639-be45-530a226401f0 | 2023-12-11 | Warnings | M016 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 245663 | zinc oxide 15 % Topical Ointment | PSN | ea608b09-a043-7457-e053-2995a90a48af | 2 |
| 245663 | zinc oxide 0.15 MG/MG Topical Ointment | SCD | ea608b09-a043-7457-e053-2995a90a48af | 2 |
| 245663 | zinc oxide 15 % Topical Ointment | SY | ea608b09-a043-7457-e053-2995a90a48af | 2 |
| 245663 | ZNO 0.15 MG/MG Topical Ointment | SY | ea608b09-a043-7457-e053-2995a90a48af | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 75523-200-02 | 75523020002 | 57 g in 1 TUBE (75523-200-02) | 57 g | 2022-10-19 | 0000-00-00 | No | No | Current |