Soothe and Cool Free Moisture Barrier
- Product NDC
- 53329-072
- Requested package NDC
- 53329-072-96
- 11-digit product format
- 533290072
- Labeler code
- 53329
- Product ID
- 53329-072_e9b0c006-8e8d-c5e5-e053-2995a90adb16
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Petrolatum
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- Medline Industries, LP
- Application
- M016
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2007-01-01
- Marketing end
- 0000-00-00
- Substance
- PETROLATUM
- Active strength
- 93 g/100g
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 package | package | 53329-072 | 53329-072-96 | D | Discontinued by firm | 2026-10-21 |
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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | I | Inactivated by FDA | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | I | Inactivated by FDA | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | I | Inactivated by FDA | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 60c52429-fcef-eb54-2387-43bc9e4f296b | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 53329-072-16 | 2024-07-30 | 072 Soothe and Cool® Moisture Barrier |
| 53329-072-96 | 2024-07-30 | 072 Soothe and Cool® Moisture Barrier |
| 53329-072-16 | 2024-01-30 | 072 Soothe and Cool® Moisture Barrier |
| 53329-072-96 | 2024-01-30 | 072 Soothe and Cool® Moisture Barrier |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 53329-072-16 | GM - Gram | 53329-072 | 76058714-78ee-4305-9591-ce9a23f5aa37 | 1 | 2019-08-06 |
| 53329-072-96 | GM - Gram | 53329-072 | a5d31cf3-2ac0-4059-9601-659e2a74d3dc | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| Vitamin A and D | VITAMIN A AND D | MIDWOOD BRANDS, LLC | 1d0ebe9a-cbc5-1765-e063-6294a90aa476 | 2024-07-18 | Warnings | M016 |
| Kidgets Baby Petroleum Jelly | BABY PETROLEUM JELLY | MIDWOOD BRANDS, LLC. | 1d0eb8be-13b7-c466-e063-6294a90a93b9 | 2024-07-11 | Warnings | M016 |
| Ivarest | ZINC OXIDE, BENZYL ALCOHOL, AND DIPHENHYDRAMINE HYDROCHLORIDE | Blistex Inc | 6f68cbbb-6269-4bb3-8cc9-50b146703b42 | 2024-07-09 | Warnings | M016 |
| Best Choice Diaper Rash | ZINC OXIDE | Trifecta Pharmaceuticals USA LLC | 1be37841-e0a8-a0de-e063-6294a90a9eb1 | 2024-06-27 | Warnings | M016 |
| Gas Relief Ultra Strength | SIMETHICONE | Walgreens | 00a9164a-1817-4130-9c7f-9f5833c9690f | 2024-06-26 | Warnings | M016 |
| Astonea Skin Protectant | ZINC OXIDE | ASTONEA LABS PRIVATE LIMITED | e3c7a515-3e77-da85-e053-2995a90a3ee1 | 2024-06-25 | Warnings | M016 |
| Astonea Vitamin A and D | WHITE PETROLATUM | ASTONEA LABS PRIVATE LIMITED | ef7c357b-5ff6-b9d7-e053-2a95a90a1dcf | 2024-06-25 | Warnings | M016 |
| ZOEY NATURALS DIAPER Cream | ZINC OXIDE | Absolutely Natural | 70fac4d6-8833-4799-b6b6-796f8f13f80e | 2024-06-25 | Warnings | M016 |
| Medicated Body | MENTHOL AND ZINC OXIDE | Universal Distribution Center LLC | 2a59a847-cc7a-42cf-b49a-92e7254c1629 | 2024-06-19 | Warnings | M016 |
| THERA Moisturizing Body Shield | DIMETHICONE | McKesson Medical-Surgical Inc. | 56869b64-11ee-4df6-8102-ce5818e0116e | 2024-06-18 | Warnings | M016 |
| Dimethicone | SKIN PROTECTANT | McKesson | 96886b33-44d4-5a2a-e053-2a95a90a505e | 2024-06-18 | Warnings | M016 |
| Derma E Eczema Relief | OATMEAL | derma e | 767c4a76-8ccb-4530-9b4b-a7ea1a596c7f | 2024-06-18 | Warnings | M016 |
| Insect sting relief pad 01 | SODIUM BICARBONATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 1b0f0088-6482-6de7-e063-6294a90aeeb7 | 2024-06-17 | Warnings | M016 |
| THERA Calazinc Body Shield | ZINC OXIDE | McKesson Medical-Surgical Inc. | 974b1046-83ee-4207-91d3-40982beb9c63 | 2024-06-17 | Warnings | M016 |
| Dimethicone | BODY CLEANSER | McKesson | 8ffe6ec3-8f5f-0c9b-e053-2995a90ac3a8 | 2024-06-14 | Warnings | M016 |
| Dr. Mom Butt Balm | DIMETHICONE PETROLATUM | Ferndale Laboratories, Inc. | ec06f1fd-c3e1-5dfc-e053-2a95a90a7cdd | 2024-06-13 | Warnings | M016 |
| Secura Protective | PETROLATUM | Smith & Nephew Medical Ltd | 20906566-fbf2-46d9-a5d8-c7f7356d1080 | 2024-06-12 | Warnings | M016 |
| Calamine | FERRIC OXIDE RED | NuCare Pharmaceuticals,Inc. | 66e98554-e158-a519-e053-2a91aa0a6783 | 2024-06-06 | Warnings, Adverse reactions | M016 |
| CVS Health Vitamin A and D Skin Protectant | LANOLIN AND PETROLATUM | CVS Health | fe3ccabb-9644-4091-9dca-ffd96a43ecaf | 2024-05-28 | Warnings | M016 |
| Babo Botanicals Sensitive Baby Fragrance Free Diaper Rash | ZINC OXIDE | Babo Botanicals, Inc. | 186a9642-cd73-adfb-e063-6394a90a75c7 | 2024-05-14 | Warnings | M016 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53329-072-96 | 53329007296 | 144 PACKET in 1 CARTON (53329-072-96) > 5 g in 1 PACKET (53329-072-16) | 144 packet | 2007-01-01 | 0000-00-00 | No | No | Current |