Soothe and Cool
- Product NDC
- 53329-067
- 11-digit product format
- 533290067
- Labeler code
- 53329
- Product ID
- 53329-067_efceb3a5-8762-fb96-e053-2995a90a1c8f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- White 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
- 935 mg/g
- 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 | 53329-067 | D | Discontinued by firm | 2026-10-23 | ||
| excluded package | package | 53329-067 | 53329-067-04 | 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 | Dataset | Scope | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 53329-067-04 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 53329-067-04 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 53329-067-04 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 53329-067-04 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 53329-067-04 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 53329-067-04 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | I | Inactivated by FDA | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 53329-067-04 | I | Inactivated by FDA | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | I | Inactivated by FDA | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 53329-067-04 | I | Inactivated by FDA | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | I | Inactivated by FDA | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 53329-067-04 | I | Inactivated by FDA | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 53329-067-04 | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 53329-067-04 | 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 |
|---|---|---|---|
| a1367f07-14a3-4895-a6e7-61ee9285308b | Product name | 1 | 20190415 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53329-067-04 | 2024-07-30 | C162847 | 48780-1 | 1030e365-1dcd-111a-e063-dadaa90a10e2 | 067 Soothe and Cool Protect A&D |
| 53329-067-04 | 2024-01-30 | C162847 | 48780-1 | 1030e365-1dcd-111a-e063-dadaa90a10e2 | 067 Soothe and Cool Protect A&D |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 53329-067-04 | GM - Gram | 53329-067 | ec3485a5-715b-4b22-84f8-bd555cc40374 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Petrolatum | ACTIVE INGREDIENT | 4T6H12BN9U | VITAMINS A AND D OINTMENT (WHITE PETROLATUM) OINTMENT [MEDLINE INDUSTRIES, INC.] | 1 | |
| Petrolatum | ACTIVE MOIETY | 4T6H12BN9U | VITAMINS A AND D OINTMENT (WHITE PETROLATUM) OINTMENT [MEDLINE INDUSTRIES, INC.] | 1 | |
| Corn Oil | INACTIVE INGREDIENT | 8470G57WFM | VITAMINS A AND D OINTMENT (WHITE PETROLATUM) OINTMENT [MEDLINE INDUSTRIES, INC.] | 1 | |
| Light Mineral Oil | INACTIVE INGREDIENT | N6K5787QVP | VITAMINS A AND D OINTMENT (WHITE PETROLATUM) OINTMENT [MEDLINE INDUSTRIES, INC.] | 1 | |
| Vitamin A Palmitate | INACTIVE INGREDIENT | 1D1K0N0VVC | VITAMINS A AND D OINTMENT (WHITE PETROLATUM) OINTMENT [MEDLINE INDUSTRIES, INC.] | 1 |
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 |
|---|---|---|---|---|---|---|
| Dermoia Eczema Relief Colloidal Oatmeal | OATMEAL | Treasurewise LLC | 1285c0a4-5fdf-4691-a8c6-1de8e2e2f66a | 2026-05-27 | Warnings | M016 |
| Calaclear | PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE | Wal-Mart Stores, Inc. | 61e76e2a-fc46-7a64-e053-2991aa0a56a8 | 2026-05-26 | Warnings | M016 |
| Calamine | CALAMINE AND ZINC OXIDE | Wal-Mart Stores, Inc. | 61929c97-bd6b-0d7c-e053-2991aa0aa571 | 2026-05-26 | Warnings | M016 |
| Calamine | CALAMINE AND ZINC OXIDE | Pharma Nobis, LLC | fbcfa541-beda-06de-e053-6294a90a9298 | 2026-05-26 | Warnings | M016 |
| Humco Calamine | CALAMINE 8% AND ZINC OXIDE 8% | Humco holding Group, Inc. | f7dcd959-fb98-43bb-8dd3-a662bf8a053c | 2026-05-26 | Warnings | M016 |
| Advanced Healing | PETROLATUM | CVS Pharamacy, Inc | 0bd3380e-2284-44a7-b2ef-68c9909627fd | 2026-05-26 | Warnings, Adverse reactions | M016 |
| CeraVe Developed with Dermatologists Healing Lip Balm | PETROLATUM | L'Oreal USA Products Inc | 21dc8842-0672-4d46-bcea-b8e3d54c48bf | 2026-05-20 | Warnings | M016 |
| AFTER CARE | DIMETHICONE | Merz North America | c19c5ffe-3b62-43e1-83c2-d89c7b9aa2ae | 2026-05-20 | Warnings | M016 |
| Zinc Oxide 20% | ZINC OXIDE | Trifecta Pharmaceuticals USA | 63b551fc-7d16-c099-e053-2a91aa0a5f2c | 2026-05-18 | Warnings | M016 |
| ADVANCED SILICONE SCAR | ALLANTOIN | Yantai Aien Biotechnology Co., Ltd. | 51ffdc45-5acf-ae20-e063-6294a90a55e8 | 2026-05-17 | Warnings | M016 |
| LCFateLC Nail Liquid | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 51ea23f4-0a23-4ae1-e063-6394a90aa051 | 2026-05-16 | Warnings | M016 |
| Radlive Active Defense Nano-Silver Cream | COLLOIDAL OATMEAL | SilverCeuticals | 51e23135-008d-9db5-e063-6294a90a7d61 | 2026-05-15 | Warnings | M016 |
| Cerave Developed with Dermatologists Healing | PETROLATUM | LOreal USA Products Inc | de44ac01-ba17-4f97-ac12-9ea348013bde | 2026-05-14 | Warnings | M016 |
| Triple 3x Max Diaper Rash | ZINC OXIDE | Advantice Health, LLC | e554046b-cd0a-4a6e-8f24-2e610c697432 | 2026-05-14 | Warnings | M016 |
| Eczema Therapy | COLLOIDAL OATMEAL | SilverCeuticals | 3a26a35e-a098-0e22-e063-6294a90a96b9 | 2026-05-13 | Warnings | M016 |
| Nail- Pflaster | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 519681bc-6312-f627-e063-6394a90a2845 | 2026-05-11 | Warnings | M016 |
| Hydrating | PETROLATUM | Aldermed Inc. | 4aa6a354-e487-4b65-e063-6394a90abbf0 | 2026-05-09 | Warnings | M016 |
| Diaper Rash | ZINC OXIDE | Aldermed Inc. | 4aa79292-dc91-b538-e063-6294a90ac3f0 | 2026-05-09 | Warnings | M016 |
| XIMONTH Nail Fungus Care Liquid | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 514a998d-aa2a-46b6-e063-6294a90a6c22 | 2026-05-08 | Warnings | M016 |
| Daily Moisturizing | DIMETHICONE | Aldi, Inc | 118a1a07-7283-4353-97b5-6ac3b1cc1430 | 2026-05-08 | Warnings, Adverse reactions | M016 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53329-067-04 | 53329006704 | 113 g in 1 TUBE (53329-067-04) | 113 g | 2007-01-01 | 0000-00-00 | No | No | Current |