Soothe and Cool Protect
- Product NDC
- 53329-993
- 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 product | product | 53329-993 | D | Discontinued by firm | 2026-10-21 | ||
| excluded package | package | 53329-993 | 53329-993-04 | D | Discontinued by firm | 2026-10-21 |
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 | 53329-993-04 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 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 | 53329-993-04 | I | Inactivated by FDA | 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.
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 |