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 |
|---|---|---|---|---|---|---|
| Calamine | FERRIC OXIDE RED | Perrigo Direct, Inc | 256bd1d4-fd50-408f-9aee-84f218bb4971 | 2026-02-19 | Warnings, Adverse reactions | M016 |
| Petroleum | WHITE PETROLATUM | Perrigo Direct, Inc | e11470b2-80d6-4008-b87e-eb6aeadfce74 | 2026-02-19 | Warnings, Adverse reactions | M016 |
| Clear Anti-Itch | PRAMOXINE HCL, ZINC ACETATE | Perrigo Direct, Inc | cc0378f2-6d5f-47ec-b16a-64668b4c29cc | 2026-02-19 | Warnings, Adverse reactions | M016 |
| Calamine | CALAMINE, PRAMOXIND HCL | Perrigo Direct, Inc | 54a20ec9-ab86-4410-af94-e04393e9d4b3 | 2026-02-19 | Warnings, Adverse reactions | M016 |
| Vitamin A D | LANOLIN, PETROLATUM | Meijer, Inc. | adc3bb9b-ed8a-4b65-b44c-1d1e978c89ec | 2026-02-19 | Warnings, Adverse reactions | M016 |
| Diaper Rash | ZINC OXIDE | Meijer, Inc. | 1b72f927-c2ae-4190-a035-5d7bb9f53c15 | 2026-02-19 | Warnings, Adverse reactions | M016 |
| Petroleum Skin Protectant | WHITE PETROLATUM | Meijer, Inc. | af293cc0-ccd5-42a6-861b-c19fa6ffd06a | 2026-02-19 | Warnings, Adverse reactions | M016 |
| Healing for Babies | PETROLATUM | Meijer, Inc. | 09878fe0-0890-4af3-a3f6-d2890041e9f8 | 2026-02-19 | Warnings, Adverse reactions | M016 |
| Clear Anti-Itch | PRAMOXINE HCL, ZINC ACETATE | Meijer, Inc. | fa8ae34c-7b68-454f-8a3b-0eaa93a34092 | 2026-02-19 | Warnings, Adverse reactions | M016 |
| Baby Diaper Rash | ZINC OXIDE | Meijer, Inc. | 04bec667-a11e-42d2-a4b3-1416eebf1e8d | 2026-02-19 | Warnings, Adverse reactions | M016 |
| Healing | PETROLATUM | Meijer, Inc. | 8cb56ee4-b9d1-4a29-88c7-e6f3ac2112c1 | 2026-02-19 | Warnings, Adverse reactions | M016 |
| Calamine | CALAMINE, PRAMOXINE HCL | Meijer, Inc. | 6b369ef2-fd54-4931-a9eb-0fb42834c2ef | 2026-02-19 | Warnings, Adverse reactions | M016 |
| Dimethicone | DIMETHICONE | Meijer, Inc. | 75b91b97-ea84-4c4d-9e58-5a9ff27a778c | 2026-02-19 | Warnings, Adverse reactions | M016 |
| Colloidal oatmeal | COLLOIDAL OATMEAL | Meijer, Inc. | d36a7479-7b3b-49fe-8144-b5cce0e173fb | 2026-02-19 | Warnings, Adverse reactions | M016 |
| Daily Moisturizing | DAILY MOISTURIZING | Meijer, Inc. | 44949b46-70f2-4e52-adba-a8455da614eb | 2026-02-19 | Warnings, Adverse reactions | M016 |
| Witch Hazel | WITCH HAZEL | Meijer, Inc. | 13e4aece-5b91-4f89-a912-540bf170a8d1 | 2026-02-19 | Warnings, Adverse reactions | M016 |
| Diaper Rash | ZINC OXIDE | Target Corporation | 7fb5f9ca-cd90-4933-9fe8-907ece00458b | 2026-02-18 | Warnings, Adverse reactions | M016 |
| Calamine | FERRIC OXIDE RED | Target Corporation | d4ee05c8-ae62-45df-8783-1ed57fa030ec | 2026-02-18 | Warnings, Adverse reactions | M016 |
| Pure petroleum | WHITE PETROLATUM | Target Corporation | 5237c7f2-7135-4558-a758-4fc2a232172f | 2026-02-18 | Warnings, Adverse reactions | M016 |
| Advanced Healing | PETROLATUM | Target Corporation | 3e620e4f-9e29-9e39-e063-6394a90adeda | 2026-02-18 | Warnings, Adverse reactions | 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 |