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 |
|---|---|---|---|---|---|---|
| Arme Scar Gel | DIMETHICONE | Nanjing Ludejin Corporation Management Co., Ltd | 42e9a59a-480e-f74a-e063-6294a90a0640 | 2025-11-06 | Warnings | M016 |
| Baby Diaper Rash Cream | ZINC OXIDE | Hello Bello | 42f14aa6-5694-7727-e063-6294a90a09f3 | 2025-11-06 | Warnings | M016 |
| Atti amour Rose Anti-Aging Repair Classic Essence | NIACINAMIDE, GLYCERIN | RIVER SUNZ co.,Ltd | 1e874ac0-a993-be9e-e063-6394a90af424 | 2025-11-06 | Warnings | M016 |
| Atti amour Rose Anti-Aging Repair Eye Cream | NIACINAMIDE, GLYCERIN | RIVER SUNZ co.,Ltd | 1eeb9c36-5bd8-ec90-e063-6294a90ae4e1 | 2025-11-06 | Warnings | M016 |
| Atti amour Rose Anti-Aging Repair Serum | NIACINAMIDE, GLYCERIN | RIVER SUNZ co.,Ltd | 1eb08f86-eb2a-7f29-e063-6294a90a0516 | 2025-11-06 | Warnings | M016 |
| Atti amour Rose Anti-Aging Repair Moisturizing Cream | NIACINAMIDE, GLYCERIN | RIVER SUNZ co.,Ltd | 1eec4cfe-d5a3-3570-e063-6294a90ac38b | 2025-11-06 | Warnings | M016 |
| Spa Dry Heel Foot Relief | DIMETHICONE | Distribuidora Comercial Jafra, S.A. de C.V. | ab8a70f5-1b3e-48a4-a9f7-ebcb30d527a9 | 2025-11-05 | Warnings | M016 |
| Royal Jelly Berry Powerful Lip Care | DIMETHICONE | Distribuidora Comercial Jafra, S.A. de C.V. | 09323fbe-76b5-48c6-80a7-c35b64110a7d | 2025-11-05 | Warnings | M016 |
| Pink Eczema Cream | COLLOIDAL OATMEAL | MOOGOO SKIN CARE PTY LTD | 3b8d92d0-ab7f-8dd5-e063-6394a90aa3af | 2025-11-04 | Warnings | M016 |
| Medline | ZINC OXIDE, PETROLATUM | Medline Industries, LP | f162b1a8-65b3-13a8-e053-2a95a90a3f13 | 2025-11-04 | Warnings | M016 |
| Medline | PETROLATUM | Medline Industries, LP | f3062b61-e4c4-9f57-e053-2995a90aa028 | 2025-11-04 | Warnings | M016 |
| Sandra Plasencia Dendrobium Officinale Soothing Biofermented Mask | TITANIUM DIOXIDE | Guangzhou Meijiao Medical Biotechnology Co., Ltd. | 3cdf06f2-63f2-7a59-e063-6294a90a72ea | 2025-11-03 | Warnings | M016 |
| Witch Hazel | WITCH HAZEL | Premier Brands of America Inc. | 38583c02-497b-922c-e063-6294a90a49de | 2025-11-03 | Warnings | M016 |
| The Zoeun Omega Serum | COLLOIDAL OATMEAL | Sturgeonbio Co.,Ltd. | 4277da80-b55b-74af-e063-6394a90af325 | 2025-10-31 | Warnings | M016 |
| Witch Hazel | WITCH HAZEL | Meijer Distribution Inc | 03f23b04-e7f7-49b7-e063-6294a90ad58a | 2025-10-31 | Warnings | M016 |
| FB HYDRATING HAND SANITIZER | FB HYDRATING HAND SANITIZER | FAMILY DOLLAR SERVICES, LLC | 20b531c1-9ab0-5ff1-e063-6394a90a2975 | 2025-10-30 | Warnings | M016 |
| FB HYDRATING HAND SANITIZER | FB HYDRATING HAND SANITIZER | FAMILY DOLLAR SERVICES, LLC | 20b650bd-18fe-8696-e063-6394a90aa9a2 | 2025-10-30 | Warnings | M016 |
| FB HYDRATING HAND SANITIZER | FB HYDRATING HAND SANITIZER | FAMILY DOLLAR SERVICES, LLC | 20b5f354-3379-3d9f-e063-6294a90ae817 | 2025-10-30 | Warnings | M016 |
| Boudreauxs | ZINC OXIDE | C.B. Fleet Company, Inc. | 59d90652-a471-4f77-a3d5-88aad9dc9e13 | 2025-10-30 | Warnings | M016 |
| CVS Cools Itch Fast | HYDROCORTISONE | CVS Pharmacy, Inc. | 8a4544df-bbba-47d2-ada0-352757abc91f | 2025-10-29 | 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 |