Petroleum
- Product NDC
- 53329-068
- 11-digit product format
- 533290068
- Labeler code
- 53329
- Product ID
- 53329-068_40c14f0d-cd27-922b-e063-6394a90a375e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- White Petrolatum
- Dosage form
- JELLY
- Route
- TOPICAL
- Labeler
- Medline Industries, LP
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2018-01-01
- Substance
- PETROLATUM
- Active strength
- 1 g/g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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 | 53329-068 | 53329-068-04 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 53329-068 | 53329-068-44 | D | Discontinued by firm | 2026-10-15 |
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 | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | 53329-068-44 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 53329-068-04 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 53329-068-44 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 53329-068-04 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 53329-068-44 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 53329-068-04 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 53329-068-44 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 53329-068-04 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 53329-068-44 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 53329-068-04 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 53329-068-44 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 53329-068-04 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 53329-068-44 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 53329-068-04 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 53329-068-44 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 53329-068-04 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 53329-068-04 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 53329-068-44 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 53329-068-44 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 53329-068-04 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 53329-068-44 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 53329-068-04 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 53329-068-44 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 53329-068-04 | 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
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PETROLATUM | 1 g/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4T6H12BN9U | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 204754 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 34f3581f-39ba-4f28-9237-52f3820ab4c0 | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53329-068-01 | Petroleum | 28.4 g in 1 TUBE | JELLY | 28.4 | 17 | |
| 53329-068-01 | Petroleum | 1 in 1 BOX | JELLY | 1 | 17 | |
| 53329-068-04 | Petroleum | 118.29 g in 1 TUBE | JELLY | 118.29 | 17 | |
| 53329-068-16 | Petroleum | 5 g in 1 PACKET | JELLY | 5 | 17 | |
| 53329-068-44 | Petroleum | 113 g in 1 TUBE | JELLY | 113 | 17 | |
| 53329-068-96 | Petroleum | 144 in 1 CARTON | JELLY | 144 | 17 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 53329-068-01 | GM - Gram | 53329-068 | 2519f4ed-7728-4e58-bf47-9f93cb91d3ba | 1 | 2021-03-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| PETROLATUM | ACTIVE INGREDIENT | 4T6H12BN9U | PETROLEUM (WHITE PETROLATUM) JELLY [MEDLINE INDUSTRIES, INC.] | 7 | |
| PETROLATUM | ACTIVE MOIETY | 4T6H12BN9U | PETROLEUM (WHITE PETROLATUM) JELLY [MEDLINE INDUSTRIES, INC.] | 7 |
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 |
|---|---|---|---|---|---|---|
| First Aid Beauty FAB Ultra Repair Body Skin Protectant | COLLOIDAL OATMEAL | The Procter & Gamble Manufacturing Company | 1a9d86fc-ef32-baed-e063-6394a90a7d74 | 2026-03-12 | Warnings | M016 |
| Meijer Scar Gel | ALLANTOIN 0.5% | Meijer | 4c108c34-72f3-1382-e063-6394a90a7f2c | 2026-03-11 | Warnings | M016 |
| E2 hand wash | E2 SANITIZING HAND SOAP | Horizon Tool Inc. | a40afa46-a07d-f864-e053-2a95a90aef8a | 2026-03-11 | Warnings | M016 |
| First Aid Beauty FAB Ultra Repair Skin Protectant Sugar Cookie | COLLOIDAL OATMEAL | The Procter & Gamble Manufacturing Company | 4576cd28-9530-4db4-e063-6394a90a9fd3 | 2026-03-10 | Warnings | M016 |
| Diaper Rash | ZINC OXIDE | Lidl US, LLC | e399b33f-5f7c-47eb-8e9b-1721ae4680b5 | 2026-03-10 | Warnings, Adverse reactions | M016 |
| Vitamin A D | WHITE PETROLATUM | Sion Biotext Medical Ltd. | 503c4ab9-1f60-48e2-af47-7ef996466a5b | 2026-03-09 | Warnings | M016 |
| Trstay | RETINOL SERUM | Shenzhen yuehaotong Technology Co.,Ltd | 4c6e20dd-0a71-a96b-e063-6294a90ab833 | 2026-03-07 | Warnings | M016 |
| 2-Pack Facial Serum | 2-PACK FACIAL SERUM | Guangzhou Ariel Biotech Co., Ltd. | 27c7f645-cfb3-6db1-e063-6394a90a42ff | 2026-03-06 | Warnings | M016 |
| 2-Pack Facial Serum | 2-PACK FACIAL SERUM | Guangzhou Ariel Biotech Co., Ltd. | 27c89fc6-016b-d359-e063-6394a90a5602 | 2026-03-06 | Warnings | M016 |
| Boudreauxs | ZINC OXIDE | C.B. Fleet Company, Inc. | f8f626c8-13ae-4b3b-ae3f-e0dc800fcb4a | 2026-03-06 | Warnings | M016 |
| First Aid Beauty FAB Ultra Repair Rescue Barrier Balm Skin Protectant | DIMETHICONE | The Procter & Gamble Manufacturing Company | 276c68d4-e273-4e48-e063-6294a90ab16f | 2026-03-04 | Warnings | M016 |
| Nicotine Patches | NICOTINE PATCHES | Zhejiang FTA Shengzuozhi Biotechnology Co., LTD | 4c1d00b3-313b-933f-e063-6294a90ac46f | 2026-03-03 | Warnings | M016 |
| Zinc Oxide | ZINC OXIDE | Amazon.com Services LLC | 495fffd7-7b64-954a-e063-6394a90a81fd | 2026-03-03 | Warnings, Adverse reactions | M016 |
| Calamine | CALAMINE, PRAMOXINE HCL | Amazon.com Services LLC | aceb0b10-8c90-4a06-8c47-cd1a2b4676a3 | 2026-03-03 | Warnings, Adverse reactions | M016 |
| Witch Hazel | WITCH HAZEL | Amazon.com Services LLC | 134e07a1-5236-4088-baf9-1ff33126f793 | 2026-03-03 | Warnings, Adverse reactions | M016 |
| Diaper Rash | ZINC OXIDE | Old East Main Co. | 7f56ab98-dbd8-412a-8c31-bb6302b7f329 | 2026-03-02 | Warnings, Adverse reactions | M016 |
| Calamine | FERRIC OXIDE RED | Old East Main Co. | c38c77fd-abbf-4c87-a9c0-a0e21ed3f97d | 2026-03-02 | Warnings, Adverse reactions | M016 |
| Pure petroleum | WHITE PETROLATUM | Old East Main Co. | ae8583c0-1b52-461d-8506-ec7524f1b4c4 | 2026-03-02 | Warnings, Adverse reactions | M016 |
| Healing for Babies | PETROLATUM | Old East Main Co. | aa1acc24-56af-4708-bf76-23d4de3d089e | 2026-03-02 | Warnings, Adverse reactions | M016 |
| Petroleum | WHITE PETROLATUM | Old East Main Co. | de8d8071-ecb2-4719-8c7b-7944f27810d6 | 2026-03-02 | Warnings, Adverse reactions | M016 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 204754 | petrolatum 100 % Topical Jelly | PSN | 34f3581f-39ba-4f28-9237-52f3820ab4c0 | 17 |
| 204754 | petrolatum 1 MG/MG Topical Ointment | SCD | 34f3581f-39ba-4f28-9237-52f3820ab4c0 | 17 |
| 204754 | petrolatum 100 % Topical Jelly | SY | 34f3581f-39ba-4f28-9237-52f3820ab4c0 | 17 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53329-068-01 | 53329006801 | 1 TUBE in 1 BOX (53329-068-01) / 28.4 g in 1 TUBE | 1 tube | 2018-01-01 | 0000-00-00 | No | No | Current |
| 53329-068-04 | 53329006804 | 118.29 g in 1 TUBE (53329-068-04) | 118.29 g | 2019-02-21 | 0000-00-00 | No | No | Current |
| 53329-068-16 | 53329006816 | 5 g in 1 PACKET (53329-068-16) | 5 g | 2018-01-01 | 0000-00-00 | No | No | Current |
| 53329-068-44 | 53329006844 | 113 g in 1 TUBE (53329-068-44) | 113 g | 2018-01-01 | 2022-01-01 | No | No | Current |
| 53329-068-96 | 53329006896 | 144 PACKET in 1 CARTON (53329-068-96) / 5 g in 1 PACKET (53329-068-16) | 144 packet | 2018-01-01 | 0000-00-00 | No | No | Current |