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 | 2026-10-27 | ||
| excluded package | package | 53329-067 | 53329-067-04 | D | Discontinued by firm | 2026-10-27 |
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 |
|---|---|---|---|---|---|---|
| MILKBODyLotion | UREA | Shengnan (Guangzhou) Cosmetics Co., LTD | 2ac99028-a811-9332-e063-6294a90aee5c | 2025-01-03 | Warnings | M016 |
| Royal Jelly Scar Balm | DIMETHICONE | Distribuidora Comercial Jafra, S.A. de C.V. | 27be84c1-0227-41ca-beb6-3855eff77e41 | 2025-01-02 | Warnings | M016 |
| Vitamin A and D | PETROLATUM | Trifecta Pharmaceuticals USA LLC | f1ea9640-4a6d-1c76-e053-2a95a90ad3b1 | 2024-12-31 | Warnings | M016 |
| Badger Diaper | ZINC OXIDE | W.S. Badger Company, Inc. | 674542b2-33fb-4664-857d-4ff1d7f768a0 | 2024-12-31 | Warnings | M016 |
| A and D Diaper Rash and Skin Protectant | LANOLIN AND PETROLATUM | Natureplex LLC | fcaf27c9-3634-4fb7-a311-2e093f055278 | 2024-12-31 | Warnings | M016 |
| ELIZABETH ARDEN EIGHT HR PROTECTANT CLEAR | LIP PROTECTANT | REVLON CONSUMER PRODUCTS CORP | f3a6fe29-7af7-bfb1-e053-2a95a90a0101 | 2024-12-30 | Warnings | M016 |
| SkinCeuticals Advanced Scar Control Skin Protectant | ALLANTOIN | L'Oreal USA Products Inc | 83f4bfbb-47d8-4fe9-ba33-85142ec6221c | 2024-12-28 | Warnings | M016 |
| Personal Cleansing with Dimethicone | DIMETHICONE | Cardinal Health 200, Inc | 3f9a1a90-ab12-4911-b8c2-df200b0dde5b | 2024-12-27 | Warnings | M016 |
| NUDESCREEN DAILY MINERAL VEIL SPF 30 - TINT NUDE | ZINC OXIDE | Bentley Laboratories, LLC | a35ae585-f899-4c7e-8cd2-c0b2fe6a2078 | 2024-12-27 | Warnings | M016 |
| NUDESCREEN DAILY MINERAL VEIL SPF 30 - TINT TAN | ZINC OXIDE | Bentley Laboratories, LLC | 7920708a-6fa7-4bc8-94ba-096e77d9d7e1 | 2024-12-27 | Warnings | M016 |
| AD Medicated Rash | AD MEDICATED RASH | WellSpring Pharmaceutical Corporation | aac345bf-ea66-4f5b-a497-c24ea72f93ea | 2024-12-27 | Warnings | M016 |
| ZO Skin Health Post Procedure Recovery System | ALUMINUM ACETATE | ZO Skin Health, Inc. | 3b977415-2bf4-43a9-bb48-1eb023ca4f53 | 2024-12-27 | Warnings | M016 |
| terrasil Scar Recovery | ALLANTOIN | Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions | 2a2f91ff-a447-9d2a-e063-6394a90a84f8 | 2024-12-26 | Warnings | M016 |
| WITCH HAZEL | WITCH HAZEL | CHAIN DRUG MARKETING ASSOCIATION INC | bdccee3f-0ad8-4264-a65f-ae86aed6bf03 | 2024-12-26 | Warnings | M016 |
| All Over Lavender Rosemary | COLLOIDAL OAT OINTMENT | Tubby Todd | 29f46671-7467-95c9-e063-6294a90a1354 | 2024-12-23 | Warnings | M016 |
| Sweet Cheeks Diaper Sprayer | ZINC OXIDE DIAPER PASTE SPRAY | Tubby Todd | 29f4aa3c-d10e-52a5-e063-6294a90acc4b | 2024-12-23 | Warnings | M016 |
| calamine | CALAMINE AND ZINC OXIDE | WALGREEN COMPANY | fed3026b-3473-26fe-e053-6294a90a8aa2 | 2024-12-23 | Warnings | M016 |
| CUREFINI | PETROLATUM, COD LIVER OIL | Miramar Cosmetics, Inc DBA Miramar Lab | fc9211db-71aa-44d8-a00b-65f1482d3981 | 2024-12-23 | Warnings | M016 |
| CUREFINI | PETROLATUM | Miramar Cosmetics, Inc DBA Miramar Lab | 6a2610ca-ca80-451f-8fed-b982443a10b9 | 2024-12-23 | Warnings | M016 |
| Vitamin A and D | LANOLIN, PETROLATUM | Trifecta Pharmaceuticals USA LLC | 453dffec-de9d-0eac-e054-00144ff8d46c | 2024-12-20 | Warnings | 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 |