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 | 2026-08-17 | |
| excluded package | package | 53329-068 | 53329-068-44 | D | Discontinued by firm | 2026-08-17 |
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… |
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 |
|---|---|---|---|---|---|---|
| Hair Regrowth Foam | GLYCERIN | Shantou Ouhoe Technology Co., Ltd. | 59ef5953-e96f-5707-e063-6294a90a3094 | 2026-08-26 | Warnings | M016 |
| Acne Relief | SALICYLIC ACID,NIACINAMIDE,PANTHENOL. | Guangzhou Senmai Biotechnology Co.,Ltd. | 59db0143-de57-59d2-e063-6294a90a32a8 | 2026-08-25 | Warnings | M016 |
| Witch Hazel | WITCH HAZEL | Your Military Exchanges | 4079fd56-55f3-4e69-93e0-7590c07fb794 | 2026-08-25 | Warnings, Adverse reactions | M016 |
| Salicylic Acid Acne Gel Cleanser | SALICYLIC ACID,PANTHENOL | Guangzhou Senmai Biotechnology Co.,Ltd. | 59eb395b-493b-efc9-e063-6294a90aa891 | 2026-08-25 | Warnings | M016 |
| Claravie | DIMETHICONE | Gentell LLC | 59c6da39-b5f1-8253-e063-6394a90a0e8f | 2026-08-24 | Warnings | M016 |
| MUSTELA Diaper Rash 1 2 3 | ZINC OXIDE | Expanscience Laboratories d/b/a Mustela | 59cf1d1e-e951-9d58-e063-6394a90af0f3 | 2026-08-24 | Warnings | M016 |
| Claravie | ZINC OXIDE, DIMETHICONE | Gentell LLC | 598a5c0b-1e2f-1335-e063-6394a90ac4f4 | 2026-08-21 | Warnings | M016 |
| MUSTELA Diaper Rash 1 2 3 | ZINC OXIDE | Expanscience Laboratories d/b/a Mustela | 163f388e-849d-4b7e-93c1-9045d77a9ec2 | 2026-08-21 | Warnings | M016 |
| Medline | WHITE PETROLATUM, ZINC OXIDE | Medline Industries, LP | 0073de92-585d-e01a-e063-6394a90a2ec2 | 2026-08-21 | Warnings | M016 |
| Mederma PM | DIMETHICONE | L Perrigo Company | 8c728904-28f4-4333-a9ea-20996fd1b007 | 2026-08-21 | Warnings | M016 |
| Earths Care Hemorrhoid Relief | WITCH HAZEL AND MENTHOL, UNSPECIFIED FORM | DLC Laboratories, Inc. | e860d65b-126d-4d77-8003-9d1381849ab5 | 2026-08-20 | Warnings | M016 |
| ClaraVie | PETROLATUM | Gentell LLC | 596987e4-4205-b911-e063-6294a90aa570 | 2026-08-19 | Warnings | M016 |
| ClaraVie | ZINC OXIDE | Gentell LLC | 596abd98-17d7-2a22-e063-6294a90af57d | 2026-08-19 | Warnings | M016 |
| Claravie Skin Repair Cream | DIMETHICONE | Gentell LLC | 596ae269-172e-aef5-e063-6394a90a4e2a | 2026-08-19 | Warnings | M016 |
| Claravie | LANOLIN | Gentell LLC | 596c1b73-e34d-c97d-e063-6394a90ada1b | 2026-08-19 | Warnings | M016 |
| ClaraVie | MENTHOL, ZINC OXIDE | Gentell LLC | 596c467f-a056-ea78-e063-6394a90a79f2 | 2026-08-19 | Warnings | M016 |
| ClaraVie | LANOLIN | Gentell LLC | 596fe32d-be34-0635-e063-6394a90a2fc0 | 2026-08-19 | Warnings | M016 |
| Medpride | ZINC OXIDE | Shield Line LLC | e2689cae-e347-4c0b-825b-6281a0b7c2f1 | 2026-08-18 | Warnings | M016 |
| Eczema Skin Relief Cream | COLLOIDAL OATMEAL | CVS Health | 98fac854-f7b0-4c6e-888d-1bdc6b9323b9 | 2026-08-17 | Warnings | M016 |
| Zinc Oxide | ZINC OXIDE | ADUSA Distribution, LLC | 5940399c-31e3-6d51-e063-6294a90a8e7c | 2026-08-17 | 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 |