Soothe and Cool Moisture Barrier
- Product NDC
- 53329-071
- 11-digit product format
- 533290071
- Labeler code
- 53329
- Product ID
- 53329-071_e9b0b9fd-5057-7b6b-e053-2995a90a9d71
- 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
- 2006-03-01
- Marketing end
- 0000-00-00
- Substance
- PETROLATUM
- Active strength
- 98 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 product | product | 53329-071 | D | Discontinued by firm | 2026-10-16 | ||
| excluded package | package | 53329-071 | 53329-071-14 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 53329-071 | 53329-071-15 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 53329-071 | 53329-071-16 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 53329-071 | 53329-071-96 | D | Discontinued by firm | 2026-10-16 |
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.
| Dataset | Scope | Package NDC |
|---|---|---|
| excluded product | product | |
| excluded package | package | 53329-071-14 |
| excluded package | package | 53329-071-15 |
| excluded package | package | 53329-071-16 |
| excluded package | package | 53329-071-96 |
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 |
|---|---|---|
| 53329-071-14 | 2023-08-08 | 071 Soothe & Cool Moisture Barrier Ointment |
| 53329-071-15 | 2023-08-08 | 071 Soothe & Cool Moisture Barrier Ointment |
| 53329-071-16 | 2023-08-08 | 071 Soothe & Cool Moisture Barrier Ointment |
| 53329-071-96 | 2023-08-08 | 071 Soothe & Cool Moisture Barrier Ointment |
| 53329-071-14 | 2023-07-28 | 071 Soothe & Cool Moisture Barrier Ointment |
| 53329-071-15 | 2023-07-28 | 071 Soothe & Cool Moisture Barrier Ointment |
| 53329-071-16 | 2023-07-28 | 071 Soothe & Cool Moisture Barrier Ointment |
| 53329-071-96 | 2023-07-28 | 071 Soothe & Cool Moisture Barrier Ointment |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 53329-071-15 | GM - Gram | 53329-071 | ad0179fe-7181-45ac-92fb-67246b68165c | 1 | 2014-12-01 |
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 |
|---|---|---|---|---|---|---|
| EIGHT HOUR SKIN FRAGRANCE FREE | PETROLATUM | REVLON | b61d6e2e-18dd-37d2-e053-2a95a90af57b | 2025-08-01 | Warnings | M016 |
| Vigority Wild Yam Cream | ESTRIOL CREAM | FOUNDATION COMMERCE INC | 39b2bef7-46c5-9ad5-e063-6294a90ae983 | 2025-07-30 | Warnings | M016 |
| Rugby Caldyphen Clear | PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTION | Rugby Laboratories | 9af3a740-ef97-26ce-e053-2a95a90a0ee1 | 2025-07-28 | Warnings | M016 |
| Aveeno Baby Eczema Therapy Soothing Bath Treatment | OATMEAL | Kenvue Brands LLC | e7eb10b7-3950-49cb-ba73-11e7581b6be9 | 2025-07-25 | Warnings | M016 |
| ProCure SkinGuard | PETROLATUM 49.9% | Twin Med LLC | 3a1721f6-1bb0-cd47-e063-6394a90a148e | 2025-07-25 | Warnings | M016 |
| ProCure HydroCerin | PETROLATUM 33% | Twin Med LLC | 3ab7248d-b914-9fdd-e063-6294a90ac4c8 | 2025-07-24 | Warnings | M016 |
| AD PREVENT Original | AD PREVENT ORIGINAL | WellSpring Pharmaceutical Corporation | cf73246e-81c1-42e9-a107-dc6c99cf7d01 | 2025-07-24 | Warnings | M016 |
| Dimethicone 1 Skin Protectant | DIMETHICONE | Universal Distribution Center LLC | 2c5b96b9-24d6-4223-a63d-fe83d7c02368 | 2025-07-24 | Warnings | M016 |
| Dr Butlers Soothing Incontinence | MINERAL OIL 59.8%, PETROLATUM 36.0% | Beyond Health PA | 3a9d3796-fd05-fe57-e063-6294a90a0ac6 | 2025-07-23 | Warnings | M016 |
| A and D plus E | VITAMIN A, D AND E OINTMENT | Derma Sciences Canada Inc. | 35aca592-bfd0-652f-e063-6394a90ac53e | 2025-07-22 | Warnings | M016 |
| Petroleum Jelly | PETROLATUM | Derma Sciences Canada Inc. | 3a895e6c-da8d-db9b-e063-6394a90ace40 | 2025-07-22 | Warnings | M016 |
| Petroleum Jelly | PETROLEUM JELLY | NeilMed Pharmaceuticals Inc. | 36bbbb1e-78e9-98f6-e063-6294a90a66d1 | 2025-07-21 | Warnings | M016 |
| Mountain Ice Eczema | COLLOIDAL OATMEAL | Mountainside Medical Equipment, Inc. | 1a91f33e-dd85-4d5a-b61c-e460a507e292 | 2025-07-21 | Warnings | M016 |
| Our Eczema Remedy | COLLOIDAL OATMEAL | Fewer Better Things | 3a755b4c-47c8-9ca5-e063-6394a90af84a | 2025-07-21 | Warnings | M016 |
| Aveeno DAILY MOISTURIZING | DIMETHICONE | Kenvue Brands LLC | 54a13b85-32b5-439d-a27a-8fba2cf44251 | 2025-07-16 | Warnings | M016 |
| ProCure Moisture Barrier | 1% DIMETHICONE, 12% ZINC OXIDE | Twin Med LLC | 3988c83b-d4eb-1f09-e063-6394a90a45ad | 2025-07-14 | Warnings | M016 |
| Avalon Organics Antidandruff Conditioner | SALICYLIC ACID | The Hain Celestial Group, Inc. | 66db1071-022a-aa19-e053-2a91aa0a8e39 | 2025-07-11 | Warnings | M016 |
| Avalon Organics Antidandruff | SALICYLIC ACID | The Hain Celestial Group, Inc. | 66c7f730-64f3-4eef-e053-2a91aa0a4225 | 2025-07-11 | Warnings | M016 |
| terrasil Infection Protection Wound Care Maximum Strength | ALLANTOIN | Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions | 9e7843e2-ca69-40f5-a4ce-da6b03ebe7f7 | 2025-07-11 | Warnings | M016 |
| terrasil Skin Repair | ALLANTOIN | Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions | 92a23c7f-6b89-49cb-93e2-49ab7a85c86d | 2025-07-11 | Warnings | M016 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53329-071-14 | 53329007114 | 56 g in 1 TUBE (53329-071-14) | 56 g | 2019-01-01 | 0000-00-00 | No | No | Current |
| 53329-071-15 | 53329007115 | 198 g in 1 TUBE (53329-071-15) | 198 g | 2019-01-01 | 0000-00-00 | No | No | Current |
| 53329-071-16 | 53329007116 | 5 g in 1 PACKET (53329-071-16) | 5 g | 2006-03-01 | 0000-00-00 | No | No | Current |
| 53329-071-96 | 53329007196 | 144 PACKET in 1 BOX (53329-071-96) > 5 g in 1 PACKET (53329-071-16) | 144 packet | 2006-03-01 | 0000-00-00 | No | No | Current |