Soothe and Cool Protect
- Product NDC
- 53329-993
- Requested package NDC
- 53329-993-04
- 11-digit product format
- 533290993
- Labeler code
- 53329
- Product ID
- 53329-993_efe1a0f9-ed14-54d7-e053-2a95a90afb80
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Petrolatum
- Dosage form
- JELLY
- Route
- TOPICAL
- Labeler
- Medline Industries, LP
- Application
- M016
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2019-04-01
- Marketing end
- 0000-00-00
- Substance
- PETROLATUM
- Active strength
- 1 g/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 package | package | 53329-993 | 53329-993-04 | D | Discontinued by firm | 2026-10-20 |
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 | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 53329-993 | 53329-993-04 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 53329-993 | 53329-993-04 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 367a005e9d99… | 383a685ebd0f… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53329-993-04 | 2024-10-23 | C162847 | 48780-1 | 1030e365-6750-111a-e063-dadaa90a10e2 | 993 Sooth & Cool Protect white petrolatum |
| 53329-993-04 | 2024-07-30 | C162847 | 48780-1 | 1030e365-6750-111a-e063-dadaa90a10e2 | 993 Sooth & Cool Protect white petrolatum |
| 53329-993-04 | 2024-01-30 | C162847 | 48780-1 | 1030e365-6750-111a-e063-dadaa90a10e2 | 993 Sooth & Cool Protect white petrolatum |
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 |
|---|---|---|---|---|---|---|
| Savvy Itch Stopping | DIPHENHYDRAMINE HYDROCHLORIDE ZINC ACETATE | Savvy Care and Cosmetics | 05ee2662-6a51-6e49-e063-6294a90a4ed7 | 2024-12-19 | Warnings | M016 |
| Health Smart Lavender Baby Petroleum | WHITE PETROLEUM | Home Smart Products | 5828df37-2a42-4129-8e4e-d5ac9c4c9615 | 2024-12-19 | Warnings | M016 |
| Petroleum Jelly | WHITE PETROLATUM | Rejoice International Inc. | 980d030a-feaf-4a81-865e-f85c66151380 | 2024-12-19 | Warnings | M016 |
| Baby Petroleum Jelly | WHITE PETROLATUM | Rejoice International Inc. | caf568aa-3889-41ff-835e-875bb6d9ca79 | 2024-12-19 | Warnings | M016 |
| Petroleum Jelly | WHITE PETROLATUM | Rejoice International Inc. | a45eb8aa-9fc9-4332-a3ef-0e6fd348fb95 | 2024-12-19 | Warnings | M016 |
| Cars Petroleum | WHITE PETROLATUM | Ultra Distributors Inc. | 9905b5a4-382e-4d2a-b971-37998c14c330 | 2024-12-19 | Warnings | M016 |
| Health Smart Aloe Vera Petroleum | WHITE PETROLEUM | Home Smart Products | 2671f2ed-af9d-4234-95bf-def368242a78 | 2024-12-19 | Warnings | M016 |
| DCH Scar | ALLANTOIN 0.5% | Derma Care Research Labs, LLC | 00edbc64-9d32-5751-e063-6294a90a400b | 2024-12-19 | Warnings | M016 |
| Bamboobies Diaper Rash | ZINC OXIDE 15% | Derma Care Research Labs, LLC | 0411f5e3-03d2-c512-e063-6394a90a37d3 | 2024-12-19 | Warnings | M016 |
| Maximum Strength Medicated Foot Powder | MEDICATED FOOT POWDER | Jell Pharmaceuticals Pvt. Ltd. | cdaae985-5363-e9d2-e053-2995a90a2682 | 2024-12-18 | Warnings | M016 |
| BABY FRESH SCENT PETROLEUM | WHITE PETROLEUM | Jell Pharmaceuticals Pvt Ltd. | d80d21cf-9463-7184-e053-2995a90a23f3 | 2024-12-18 | Warnings | M016 |
| Health Smart Baby Petroleum | WHITE PETROLEUM | Home Smart Products | edd9d018-c2c9-4a9a-b727-0a92cd463c02 | 2024-12-18 | Warnings | M016 |
| Health Smart Cocoa Butter Petroleum | WHITE PETROLEUM | Home Smart Products | a65c8267-d34f-4542-a7ca-5180e860a03d | 2024-12-18 | Warnings | M016 |
| Princess Petroleum | WHITE PETROLATUM | Ultra Distributors Inc. | 6d9c92bf-9263-40a4-acac-5c3f0b08c69d | 2024-12-18 | Warnings | M016 |
| Meijer Petroleum Jelly | WHITE PETROLATUM | Meijer Distribution, Inc | b299cf2a-2c6a-68f4-e053-2995a90a5bd7 | 2024-12-18 | Warnings | M016 |
| Foster and Thrive Caldyphen | CALAMINE AND PRAMOXINE HYDROCHLORIDE | Strategic Sourcing Services, LLC | 29945734-4ea6-b702-e063-6294a90ae6f2 | 2024-12-18 | Warnings | M016 |
| Foster and Thrive Caldyphen Clear | PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE | Strategic Sourcing Services, LLC | 29946912-9794-8a8e-e063-6394a90a279e | 2024-12-18 | Warnings | M016 |
| Caring Mills Petroleum Jelly | WHITE PETROLATUM | Veridian Healthcare | fbbfa780-0e2b-1874-e053-6394a90a5eeb | 2024-12-18 | Warnings | M016 |
| Serawise Eczema Rescue | OATMEAL | DrAnaMaria.com LLC | e805866a-2349-4b86-bc83-a7c859cb9403 | 2024-12-18 | Warnings | M016 |
| TheraCare Petroleum Jelly | WHITE PETROLATUM | Veridian Healthcare | d6fad49b-8a49-7f7c-e053-2a95a90ae638 | 2024-12-18 | Warnings | M016 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53329-993-04 | 53329099304 | 113 g in 1 TUBE (53329-993-04) | 113 g | 2019-04-01 | 0000-00-00 | No | No | Current |