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 | 2026-10-15 | ||
| excluded package | package | 53329-071 | 53329-071-14 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 53329-071 | 53329-071-15 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 53329-071 | 53329-071-16 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 53329-071 | 53329-071-96 | 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.
| 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 |
|---|---|---|---|---|---|---|
| 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 |
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 |