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 |
|---|---|---|---|---|---|---|
| Clear Anti-Itch | PRAMOXINE HCL, ZINC ACETATE | Old East Main Co. | 91df1434-bce6-4c6e-beee-cb5ec1cc8fff | 2026-03-02 | Warnings, Adverse reactions | M016 |
| Advanced Healing | PETROLATUM | Old East Main Co. | cf916191-1de2-4305-b783-9e074c1ad94b | 2026-03-02 | Warnings, Adverse reactions | M016 |
| Eczema Relief | COLLOIDAL OATMEAL | Old East Main Co. | b2dba027-c295-4a41-8d30-144904e1aa34 | 2026-03-02 | Warnings, Adverse reactions | M016 |
| Baby Eczema Therapy | COLLOIDAL OATMEAL | Old East Main Co. | 9720e2ad-1bcf-4023-8e92-22a962df3aad | 2026-03-02 | Warnings, Adverse reactions | M016 |
| Calamine | FERRIC OXIDE RED | Chain Drug Marketing Association | 86ff4875-9007-4b7b-8f46-16cbd475d4bb | 2026-02-27 | Warnings, Adverse reactions | M016 |
| Clear Anti-Itch | PRAMOXINE HCL, ZINC ACETATE | Chain Drug Marketing Association | 1ff6bd85-3658-47ea-b6ca-0eb5d8dbb693 | 2026-02-27 | Warnings, Adverse reactions | M016 |
| Calamine | CALAMINE, PRAMOXINE HCL | Chain Drug Marketing Association | 6c848b98-f01c-40f2-a9aa-2af76cb370c8 | 2026-02-27 | Warnings, Adverse reactions | M016 |
| Diaper Rash | ZINC OXIDE | The Kroger Co. | fcffbe1f-79b8-451a-9384-19533b81d8c8 | 2026-02-27 | Warnings, Adverse reactions | M016 |
| Petroleum | WHITE PETROLATUM | The Kroger Co. | d2095c7b-61ca-40d3-bbf1-04bed4dd789c | 2026-02-27 | Warnings, Adverse reactions | M016 |
| Daily Moisturizing | DIMETHICONE | The Kroger Co. | ea8b186c-82d5-4552-bcce-03e56023ea99 | 2026-02-27 | Warnings, Adverse reactions | M016 |
| Diaper Rash Cream | ZINC OXIDE | Smalls Brand LLC DBA Roe Wellness | 4bd29285-29b4-5d57-e063-6294a90af481 | 2026-02-27 | Warnings | M016 |
| Vitamin A D | LANOLIN, PETROLATUM | Walmart Inc. | 5893801a-25e1-4750-a55b-d9cddd3f1284 | 2026-02-27 | Warnings, Adverse reactions | M016 |
| Diaper Rash | ZINC OXIDE | Walmart Inc. | 320bcbd3-9e91-437f-99c5-066f880a4b32 | 2026-02-27 | Warnings, Adverse reactions | M016 |
| Skin Protectant | PETROLATUM | Walmart Inc. | eb836922-f467-42ab-a6e7-b787d97e6c17 | 2026-02-27 | Warnings, Adverse reactions | M016 |
| Advanced Healing | PETROLATUM | Walmart Inc. | aa7dbf7f-50be-475b-8140-68be3fa93507 | 2026-02-27 | Warnings, Adverse reactions | M016 |
| White Petrolatum | WHITE PETROLATUM | Walmart Inc. | 176d7711-7c4f-4319-91af-0aba1260c412 | 2026-02-27 | Warnings, Adverse reactions | M016 |
| Soothing Moisturizing | COLLOIDAL OATMEAL | Walmart Inc. | 2d813455-c268-4c6d-9952-eaf0e0007d90 | 2026-02-27 | Warnings, Adverse reactions | M016 |
| Rapid Repair Healing Cream | ALLANTOIN, DIMETHICONE | June Jacobs Labs LLC | 186c13be-5e41-b9c9-e063-6294a90ad574 | 2026-02-26 | Warnings | M016 |
| Lanashield | LANOLIN | Dynarex Corporation | 94b277dc-6512-4d36-8485-8ea510097428 | 2026-02-26 | Warnings | M016 |
| GLADSKIN ECZEMACT ECZEMA | COLLOIDAL OATMEAL | Micreos North America, Inc. | 06f9af75-c5ff-d37b-e063-6394a90a4f6c | 2026-02-25 | Warnings | 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 |