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 | 2026-10-16 | ||
| excluded package | package | 0404-0042 | 0404-0042-47 | 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 | 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 |
|---|---|---|---|---|---|---|
| EIGHT HOUR SKIN FRAGRANCE FREE | PETROLATUM | REVLON | b61d6e2e-18dd-37d2-e053-2a95a90af57b | 2025-08-01 | Warnings | M016 |
| Vigority Wild Yam Cream | ESTRIOL CREAM | FOUNDATION COMMERCE INC | 39b2bef7-46c5-9ad5-e063-6294a90ae983 | 2025-07-30 | Warnings | M016 |
| Rugby Caldyphen Clear | PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTION | Rugby Laboratories | 9af3a740-ef97-26ce-e053-2a95a90a0ee1 | 2025-07-28 | Warnings | M016 |
| Aveeno Baby Eczema Therapy Soothing Bath Treatment | OATMEAL | Kenvue Brands LLC | e7eb10b7-3950-49cb-ba73-11e7581b6be9 | 2025-07-25 | Warnings | M016 |
| ProCure SkinGuard | PETROLATUM 49.9% | Twin Med LLC | 3a1721f6-1bb0-cd47-e063-6394a90a148e | 2025-07-25 | Warnings | M016 |
| ProCure HydroCerin | PETROLATUM 33% | Twin Med LLC | 3ab7248d-b914-9fdd-e063-6294a90ac4c8 | 2025-07-24 | Warnings | M016 |
| AD PREVENT Original | AD PREVENT ORIGINAL | WellSpring Pharmaceutical Corporation | cf73246e-81c1-42e9-a107-dc6c99cf7d01 | 2025-07-24 | Warnings | M016 |
| Dimethicone 1 Skin Protectant | DIMETHICONE | Universal Distribution Center LLC | 2c5b96b9-24d6-4223-a63d-fe83d7c02368 | 2025-07-24 | Warnings | M016 |
| Dr Butlers Soothing Incontinence | MINERAL OIL 59.8%, PETROLATUM 36.0% | Beyond Health PA | 3a9d3796-fd05-fe57-e063-6294a90a0ac6 | 2025-07-23 | Warnings | M016 |
| A and D plus E | VITAMIN A, D AND E OINTMENT | Derma Sciences Canada Inc. | 35aca592-bfd0-652f-e063-6394a90ac53e | 2025-07-22 | Warnings | M016 |
| Petroleum Jelly | PETROLATUM | Derma Sciences Canada Inc. | 3a895e6c-da8d-db9b-e063-6394a90ace40 | 2025-07-22 | Warnings | M016 |
| Petroleum Jelly | PETROLEUM JELLY | NeilMed Pharmaceuticals Inc. | 36bbbb1e-78e9-98f6-e063-6294a90a66d1 | 2025-07-21 | Warnings | M016 |
| Mountain Ice Eczema | COLLOIDAL OATMEAL | Mountainside Medical Equipment, Inc. | 1a91f33e-dd85-4d5a-b61c-e460a507e292 | 2025-07-21 | Warnings | M016 |
| Our Eczema Remedy | COLLOIDAL OATMEAL | Fewer Better Things | 3a755b4c-47c8-9ca5-e063-6394a90af84a | 2025-07-21 | Warnings | M016 |
| Aveeno DAILY MOISTURIZING | DIMETHICONE | Kenvue Brands LLC | 54a13b85-32b5-439d-a27a-8fba2cf44251 | 2025-07-16 | Warnings | M016 |
| ProCure Moisture Barrier | 1% DIMETHICONE, 12% ZINC OXIDE | Twin Med LLC | 3988c83b-d4eb-1f09-e063-6394a90a45ad | 2025-07-14 | Warnings | M016 |
| Avalon Organics Antidandruff Conditioner | SALICYLIC ACID | The Hain Celestial Group, Inc. | 66db1071-022a-aa19-e053-2a91aa0a8e39 | 2025-07-11 | Warnings | M016 |
| Avalon Organics Antidandruff | SALICYLIC ACID | The Hain Celestial Group, Inc. | 66c7f730-64f3-4eef-e053-2a91aa0a4225 | 2025-07-11 | Warnings | M016 |
| terrasil Infection Protection Wound Care Maximum Strength | ALLANTOIN | Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions | 9e7843e2-ca69-40f5-a4ce-da6b03ebe7f7 | 2025-07-11 | Warnings | M016 |
| terrasil Skin Repair | ALLANTOIN | Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions | 92a23c7f-6b89-49cb-93e2-49ab7a85c86d | 2025-07-11 | 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 |