Petrolatum
- Product NDC
- 0404-0042
- 11-digit product format
- 004040042
- Labeler code
- 0404
- Product ID
- 0404-0042_f1628b72-eb7b-1590-e053-2a95a90ad4e9
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- petrolatum
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- Henry Schein, Inc.
- Application
- M016
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2011-04-05
- Marketing end
- 2025-04-01
- Substance
- PETROLATUM
- Active strength
- 1 g/g
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- 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 | 0404-0042 | D | Discontinued by firm | 2026-10-12 | ||
| excluded package | package | 0404-0042 | 0404-0042-47 | D | Discontinued by firm | 2026-10-12 |
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 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0404-0042-47 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 0404-0042-47 | f5e01cc5f278… | a2eaf40c39c3… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| PETROLATUM | ACTIVE INGREDIENT | 4T6H12BN9U | PETROLATUM OINTMENT [HENRY SCHEIN, INC.] | 5 | |
| PETROLATUM | ACTIVE MOIETY | 4T6H12BN9U | PETROLATUM OINTMENT [HENRY SCHEIN, INC.] | 5 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | PETROLATUM OINTMENT [HENRY SCHEIN, INC.] | 5 |
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 |
|---|---|---|---|---|---|---|
| SUPRADERM | WHITE PETROLATUM, LANOLIN | Olen Skin Care Corporation | 4e7199bd-52c6-48e9-9c78-c84e45412faf | 2026-06-10 | Warnings | M016 |
| Medline | DIMETHICONE | Medline Industries, LP | 509ee758-9d53-220c-e063-6394a90a4bd5 | 2026-06-09 | Warnings | M016 |
| BABY BUM DIAPER | ZINC OXIDE | Creative Consumer Products, Inc. DBA (Doing Business As) Dionis Goat Milk Skincare | 53d8a654-aaec-6f91-e063-6394a90a7351 | 2026-06-09 | Warnings | M016 |
| CELISTAR MICRONEEDLING INFUSION | HYALURONATE SODIUM | Guangdong Outeli Biotechnology Co., Ltd. | 53de46a7-3947-70a7-e063-6294a90ab829 | 2026-06-09 | Warnings | M016 |
| Medline | DIMETHICONE | Medline Industries, LP | 3c448cf7-8ca5-c7f7-e063-6294a90a75ff | 2026-06-08 | Warnings | M016 |
| WOODSLEEP Wild Yam Cream | GLYCERIN | Shantou Woodsleep Biotechnology Co., Ltd. | 53b992fd-5759-57bb-e063-6394a90a1600 | 2026-06-08 | Warnings | M016 |
| XIMONTH Fungi Free Bee Venom Nail Soothing Serum | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 53bab969-8407-6334-e063-6294a90aa5d1 | 2026-06-08 | Warnings | M016 |
| GNP Calamine Topical Suspension | CALAMINE 8% AND ZINC OXIDE 8% | Amerisource Bergen | 777b0e66-1bce-4483-9dad-c46796fd6f23 | 2026-06-04 | Warnings | M016 |
| GNP Caldyphen | CALAMINE AND PRAMOXINE HYDROCHLORIDE | Amerisource Bergen | 515c58d7-0dc4-45e7-9155-e5270a16290e | 2026-06-04 | Warnings | M016 |
| First Aid Beauty Sensitive Skin Bestsellers Kit | COLLOIDAL OATMEAL | The Procter & Gamble Manufacturing Company | 535a0e8e-6bb4-6652-e063-6394a90aa7ff | 2026-06-03 | Warnings | M016 |
| Quad Wash | DIMETHICONE | Dynarex Corporation | 535dc862-6a18-26c9-e063-6294a90a3d4a | 2026-06-03 | Warnings | M016 |
| First Aid Beauty Sensitive Skin Bestsellers Kit | COLLOIDAL OATMEAL | JCS Global Distribution, Inc. | 535e42a1-8b14-324d-e063-6394a90a3f65 | 2026-06-03 | Warnings | M016 |
| Petroleum Jelly Skin Protectant | WHITE PETROLATUM | Acme United Corporation | 535e94bb-21e8-90be-e063-6394a90a37bb | 2026-06-03 | Warnings | M016 |
| ADVANCED HEALING | PETROLATUM | Rejoice International Corp. | 532c7e5a-4d05-3bd0-e063-6294a90aee00 | 2026-06-01 | Warnings | M016 |
| PUTRIZEN 40 UREA | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 533dadbc-6f20-d880-e063-6394a90a753f | 2026-06-01 | Warnings | M016 |
| ADVANCED HEALING BALM | PETROLATUM | Rejoice International Corp. | 53285d82-3755-ca78-e063-6394a90a5019 | 2026-05-31 | Warnings | M016 |
| KIEHLS SINCE 1851 Ultra Facial Meltdown Recovery | COLLOIDAL OATMEAL | LOreal USA Products Inc | 22e088b9-b3b1-4c34-be12-a5a31200ec25 | 2026-05-29 | Warnings | M016 |
| Acne Relief Cream | NIACINAMIDE,SALICYLIC ACID,CENTELLA ASIATICA ROOT,COPTIS CHINENSIS ROOT | Guangzhou Senmai Biotechnology Co.,Ltd. | 53008b89-89ab-7650-e063-6294a90ac16c | 2026-05-29 | Warnings | M016 |
| PURE PETROLATUM | PETROLATUM | VASA COSMETICS PRIVATE LIMITED | 52efd466-49bd-bbdf-e063-6394a90aa108 | 2026-05-28 | Warnings | M016 |
| TheraCare Vitamin A and D plus E | PETROLATUM | Veridian Healthcare | 52e0e248-6c04-feb9-e063-6394a90add46 | 2026-05-28 | Warnings | M016 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0404-0042-47 | 00404004247 | 144 PACKET in 1 BOX (0404-0042-47) > 5 g in 1 PACKET (0404-0042-05) | 144 packet | 2015-06-08 | 0000-00-00 | No | No | Current |