Soothe and Cool Free Moisture Barrier
- Product NDC
- 53329-072
- Requested package NDC
- 53329-072-16
- 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 | 53329-072-16 | D | Discontinued by firm | 2026-10-23 |
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 |
|---|---|---|---|---|---|---|
| Anubis Barcelona New Even | LACTIC ACID, CITRIC ACID, GLYCOLIC ACID | ANUBIS COSMETICS SL | eaeeb6e0-5322-20c4-e053-2995a90a9fd9 | 2023-09-01 | Warnings | M016 |
| Anubis Barcelona Vital Line | HYDROLYZED COLLAGEN | ANUBIS COSMETICS SL | f564bbf0-3b5c-4a81-e053-2a95a90a7ea6 | 2023-08-29 | Warnings | M016 |
| Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen SPF 15 | CAMPHOR (SYNTHETIC), PETROLATUM | Carma Laboratories, Inc. | 5378d653-702d-405c-a067-882554aaf93a | 2023-08-21 | Warnings | M016 |
| Quality Choice Anti-itch Medicated | CALAMINE AND PRAMOXINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION INC | 5e07f26f-cfb6-57f9-e053-2991aa0a2008 | 2023-08-02 | Warnings | M016 |
| Barrier Balm | BARRIER BALM | Autumn Harp, Inc. | 01df9746-991b-4363-e063-6294a90aaac6 | 2023-08-01 | Warnings | M016 |
| Barrier Cream | ZINC OXIDE | Avasol LLC | bc6a2736-faa6-46d3-af9b-a70f0762e9ce | 2023-05-15 | Warnings | M016 |
| First Aid Beauty FAB Ultra Repair Skin Protectant Candy Cane | COLLOIDAL OATMEAL | The Procter & Gamble Manufacturing Company | bec2f702-5ff5-ea66-e053-2a95a90ad1ec | 2023-01-01 | Warnings | M016 |
| Badger After-BUG Balm | COLLOIDAL OATMEAL | W.S. Badger Company, Inc. | a623da47-cef2-146f-e053-2a95a90afe3a | 2021-11-17 | Warnings | M016 |
| Derma-e Eczema Relief | OATMEAL | Topiderm, Inc | e1797f81-af4b-49e1-9906-dbfd904a282b | 2020-08-19 | Warnings | M016 |
| Resurfix Plus | PETROLATUM | Topiderm, Inc. | f100f43d-6ace-4c3a-9c85-640c0ab2e360 | 2019-11-19 | Warnings | M016 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53329-072-16 | 53329007216 | 5 g in 1 PACKET (53329-072-16) | 5 g | 2007-01-01 | 0000-00-00 | No | No | Current |