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 | 2026-10-21 |
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 | 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 |
|---|---|---|---|---|---|---|
| EltaMD Laser Balm | PETROLATUM SKIN PROTECTANT | CP Skin Health Group, Inc | 1c67ce72-89d9-4c4f-a9b0-28b7e67d30eb | 2023-11-09 | Warnings | M016 |
| DiaperDerm Diaper Rash | ZINC OXIDE | Diaperderm Inc | 4e1fce3e-c2b7-42da-9953-1dbb13e2467c | 2023-11-06 | Warnings | M016 |
| Doctors Diaper Rash Cream | ZINC OXIDE | DOCTOR'S DIAPER RASH CREAM, INC | 0988ccb1-7881-4d97-bcbf-d0cf4316e4be | 2023-11-06 | Warnings | M016 |
| DERMOIA Manuka Honey Eczema Cream | OATMEAL | TREASUREWISE LLC | a48e52a3-b681-4489-a1fd-6b09d8bc9c55 | 2023-11-06 | Warnings | M016 |
| GL HEALTH Barrier Skin Protectant | ZINC OXIDE | GL HEALTH, INC. | 76cfa330-fea9-48d4-b187-469154765d39 | 2023-11-06 | Warnings | M016 |
| Skin-lube | PETROLATUM, DIMETHICONE | The Hygenic Company, LLC. | d1005dec-04f6-3f88-e053-2a95a90ad9cb | 2023-11-05 | Warnings | M016 |
| Dr. Sheffield Anti Itch Cream | ANTI ITCH CREAM | Sheffield Pharmaceuticals LLC | 77f0593e-f694-4c02-9fd9-ad56ff2a920c | 2023-10-30 | Warnings | M016 |
| calahist | CALAMINE AND PRAMOXINE HYDROCHLORIDE | WALGREEN COMPANY | fed45e06-cc53-fbc5-e053-6294a90a1b19 | 2023-10-27 | Warnings | M016 |
| calahist clear | PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE | WALGREEN COMPANY | fed469c2-fe13-6726-e053-6394a90a5f51 | 2023-10-27 | Warnings | M016 |
| Dr. Sayman Salve | SALVE | Sheffield Pharmaceuticals LLC | 18bdcd0c-9c81-47e1-ae24-2239ff8fd066 | 2023-10-24 | Warnings | M016 |
| Theriac Advanced Healing | LANOLIN | Sheffield Pharmaceuticals LLC | c780cd27-dc9e-45f3-97f0-e59b1b6b955a | 2023-10-24 | Warnings | M016 |
| Babo Botanicals Sensitive Baby Fragrance Free Diaper Rash | ZINC OXIDE | Babo Botanicals, Inc. | d66e369e-9b19-b084-e053-2995a90aa259 | 2023-10-23 | Warnings | M016 |
| Babo Botanicals Sensitive Baby Healing | COLLOIDAL OATMEAL | Babo Botanicals, Inc. | 08659a5c-2d10-2f98-e063-6394a90a7760 | 2023-10-23 | Warnings | M016 |
| White Rose Petroleum Jelly | PETROLATUM | J. Strickland & Co. | 1aeb090d-c103-4c2e-accc-d9d248315db9 | 2023-10-21 | Warnings | M016 |
| Tricalm Hydrogel | ALUMINUM ACETATE | MODULAR THERMAL TECHNOLOGIES LLC DBA LIFE WEAR TECHNOLOGIES | 082c6441-be47-4466-e063-6394a90ad500 | 2023-10-20 | Warnings | M016 |
| Empower | WHITE PETROLATUM, ZINC OXIDE | Bemis Manufacturing Company Inc | 08006b60-966b-155b-e063-6294a90a206a | 2023-10-18 | Warnings | M016 |
| ANUBISMED | HA HYALURONIC | ANUBIS COSMETICS SL | eac771e2-4c1b-3808-e053-2995a90ac5fc | 2023-09-05 | Warnings | M016 |
| AnubisMed | SODIUM BICARBONATE, ALOE BARBADENSIS LEAF JUICE, IMIDAZOLIDINYL UREA | ANUBIS COSMETICS SL | ebf4b3ab-34e1-185a-e053-2a95a90ace3a | 2023-09-05 | Warnings | M016 |
| Anubis Barcelona | GLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICE | ANUBIS COSMETICS SL | eb651769-4d98-2b3b-e053-2a95a90a36b0 | 2023-09-01 | Warnings | M016 |
| Anubis Barcelona | DMAE | ANUBIS COSMETICS SL | f22b212d-d21d-5984-e053-2995a90a683e | 2023-09-01 | 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 |