Petroleum Skin Protectant
- Product NDC
- 11344-069
- 11-digit product format
- 113440069
- Labeler code
- 11344
- Product ID
- 11344-069_5b88db78-8cf8-9282-e063-6394a90a08d9
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- White Petrolatum
- Dosage form
- JELLY
- Route
- TOPICAL
- Labeler
- Nice-Pak Products, LLC
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 1989-07-15
- Substance
- PETROLATUM
- Active strength
- 1 g/g
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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 package | package | 11344-069 | 11344-069-10 | D | Discontinued by firm | 2026-10-16 |
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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
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
- Petroleum Skin Protectant
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PETROLATUM | 1 g/g |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11344-069-10 | Petroleum Skin Protectant | 28.3 g in 1 TUBE | JELLY | 28.3 | 18 | |
| 11344-069-27 | Petroleum Skin Protectant | 369 g in 1 JAR | JELLY | 369 | 18 | |
| 11344-069-54 | Petroleum Skin Protectant | 106 g in 1 JAR | JELLY | 106 | 18 | |
| 11344-069-96 | Petroleum Skin Protectant | 213 g in 1 JAR | JELLY | 213 | 18 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| PETROLATUM | ACTIVE INGREDIENT | 4T6H12BN9U | PETROLEUM SKIN PROTECTANT (WHITE PETROLATUM) JELLY [VI-JON] | 1 | |
| PETROLATUM | ACTIVE MOIETY | 4T6H12BN9U | PETROLEUM SKIN PROTECTANT (WHITE PETROLATUM) JELLY [VI-JON] | 1 |
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 |
|---|---|---|---|---|---|---|
| Hydro Gel | GLYCERIN 20% | Trifecta Pharmaceuticals USA LLC | 02e8e5d0-7844-39fe-e063-6394a90a57e1 | 2024-01-19 | Warnings | M016 |
| White Petrolatum | WHITE PETROLATUM | Sled Distribution, LLC | e73a4b7a-7b27-abfc-e053-2995a90a35c2 | 2024-01-15 | Warnings | M016 |
| Sunmark Caldiphen | CALAMINE AND PRAMOXINE HYDROCHLORIDE | Strategic Sourcing Services | 4f4d4c54-64b5-4e20-bed0-c7fb470b8434 | 2024-01-12 | Warnings | M016 |
| EIGHT HOUR NIGHT | DIMETHICONE | REVLON | b3b277f9-565a-636c-e053-2995a90a94d2 | 2024-01-12 | Warnings | M016 |
| CeraVe Developed with Dermatologists Eczema Relief Creamy | OATMEAL | L'Oreal USA Products Inc | bcf7b985-6875-4033-a412-1bb6d3afa6d8 | 2024-01-01 | Warnings | M016 |
| CeraVe Developed with Dermatologists Healing | PETROLATUM | L'Oreal USA Products Inc. | 1b3ad3e8-cbac-4a92-84e2-4f3ab4512d95 | 2023-12-31 | Warnings | M016 |
| CeraVe Developed with Dermatologists Baby Healing | PETROLATUM | L'Oreal USA Products Inc. | fe665bbc-1172-4f59-acc6-8d5c179693b6 | 2023-12-31 | Warnings | M016 |
| Quality Choice Anti-Itch Clear | ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE | Chain Drug Market Association | e3c0c46d-3d85-411d-a543-009064cdd19e | 2023-12-28 | Warnings | M016 |
| CeraVe Developed with Dermatologists Therapeutic Hand | DIMETHICONE | L'Oreal USA Products Inc | 7fe49112-4180-415c-a380-768a8d6b2185 | 2023-12-28 | Warnings | M016 |
| Calaclear | PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE | Pharma Nobis, LLC | e42fccc2-1b4e-e7f3-e053-2a95a90aef39 | 2023-12-26 | Warnings | M016 |
| Calamine Phenolated Topical Suspension | CALAMINE AND ZINC OXIDE AND PHENOL | Pharma Nobis, LLC | e42fbdcc-3291-7761-e053-2995a90a7172 | 2023-12-26 | Warnings | M016 |
| Humco Calagesic | CALAMINE AND PRAMOXINE HYDROCHLORIDE | Pharma Nobis, LLC | e42fb807-8cb4-ed25-e053-2995a90a6780 | 2023-12-26 | Warnings | M016 |
| Leader Calamine Plus | ZINC OXIDE LOTION | Cardinal Health, 110 dba Leader | 81f29789-f794-1e64-e053-2a91aa0ac85e | 2023-12-22 | Warnings | M016 |
| CVS Calamine Plus | ZINC OXIDE | CVS Pharmacy | b90cd214-d44a-4458-876d-59cc0795226d | 2023-12-22 | Warnings | M016 |
| Calamine | CALAMINE 8% AND ZINC OXIDE 8% | Pharma Nobis, LLC | e42f0bd6-3ad3-7e07-e053-2995a90a564a | 2023-12-22 | Warnings | M016 |
| DDM Calamine | CALAMINE 8% AND ZINC OXIDE 8% | Discount Drug Mart | 5d53685b-ca4c-35c1-e053-2a91aa0aff6e | 2023-12-20 | Warnings | M016 |
| DDM Calagesic | ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE | Discount Drug Mart | 5d537a11-049e-0a8d-e053-2a91aa0aa0c3 | 2023-12-20 | Warnings | M016 |
| Health Mart Calamine | CALAMINE 8% AND ZINC OXIDE 8% | Strategic Sourcing Services LLC | 349ea07d-79bc-46f3-9d60-85b40db51bbb | 2023-12-20 | Warnings | M016 |
| Health Mart Witch Hazel | WITCH HAZEL | Strategic Sourcing Services LLC | 2a1d9b27-0bd4-4475-8218-ba0f5560a969 | 2023-12-20 | Warnings | M016 |
| Quality Choice Calamine | CALAMINE 8% AND ZINC OXIDE 8% | Chain Drug Market Association | 62fe653f-e861-472b-b193-4fdd9d25de8d | 2023-12-20 | Warnings | M016 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 204754 | petrolatum 100 % Topical Jelly | PSN | 0b1a09b8-6499-4f41-836a-ad839c63f74f | 18 |
| 204754 | petrolatum 1 MG/MG Topical Ointment | SCD | 0b1a09b8-6499-4f41-836a-ad839c63f74f | 18 |
| 204754 | petrolatum 100 % Topical Jelly | SY | 0b1a09b8-6499-4f41-836a-ad839c63f74f | 18 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 11344-069-10 | 11344006910 | 28.3 g in 1 JAR (11344-069-10) | 28.3 g | 1989-07-15 | 0000-00-00 | No | No | Current |
| 11344-069-27 | 11344006927 | 369 g in 1 JAR (11344-069-27) | 369 g | 1989-07-15 | 0000-00-00 | No | No | Current |
| 11344-069-54 | 11344006954 | 106 g in 1 JAR (11344-069-54) | 106 g | 1989-07-15 | 0000-00-00 | No | No | Current |
| 11344-069-96 | 11344006996 | 213 g in 1 JAR (11344-069-96) | 213 g | 1989-07-15 | 0000-00-00 | No | No | Current |