Soothe and Cool Free Moisture Barrier
- Product NDC
- 53329-072
- 11-digit product format
- 533290072
- Labeler code
- 53329
- Product ID
- 53329-072_e9b0c006-8e8d-c5e5-e053-2995a90adb16
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- 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
- 93 g/100g
- 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 | 53329-072 | D | Discontinued by firm | 2026-10-15 | ||
| excluded package | package | 53329-072 | 53329-072-16 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 53329-072 | 53329-072-96 | D | Discontinued by firm | 2026-10-15 |
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 | 53329-072-16 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 53329-072-96 | 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 | 53329-072-16 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 53329-072-96 | 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 | 53329-072-16 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 53329-072-96 | 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 | 53329-072-16 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 53329-072-96 | 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 | 53329-072-16 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 53329-072-96 | 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 | 53329-072-16 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 53329-072-96 | 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 | 53329-072-16 | I | Inactivated by FDA | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 53329-072-96 | 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 | 53329-072-16 | I | Inactivated by FDA | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 53329-072-96 | 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 | 53329-072-16 | I | Inactivated by FDA | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 53329-072-96 | 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 | 53329-072-16 | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 53329-072-96 | 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 | 53329-072-16 | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 53329-072-96 | 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 |
|---|---|---|---|
| 60c52429-fcef-eb54-2387-43bc9e4f296b | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 53329-072-16 | 2024-07-30 | 072 Soothe and Cool® Moisture Barrier |
| 53329-072-96 | 2024-07-30 | 072 Soothe and Cool® Moisture Barrier |
| 53329-072-16 | 2024-01-30 | 072 Soothe and Cool® Moisture Barrier |
| 53329-072-96 | 2024-01-30 | 072 Soothe and Cool® Moisture Barrier |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 53329-072-16 | GM - Gram | 53329-072 | 76058714-78ee-4305-9591-ce9a23f5aa37 | 1 | 2019-08-06 |
| 53329-072-96 | GM - Gram | 53329-072 | a5d31cf3-2ac0-4059-9601-659e2a74d3dc | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| 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 |
| Vitamin A and D | LANOLIN, PETROLATUM | Trifecta Pharmaceuticals USA LLC | 455a16fd-9ce5-6bef-e054-00144ff88e88 | 2024-12-20 | Warnings | M016 |
| White Petrolatum | PETROLATUM | Trifecta Pharmaceuticals USA LLC | f1eb0ec2-98e7-13a2-e053-2a95a90a2938 | 2024-12-20 | Warnings | M016 |
| Zinc Oxide 20% | ZINC OXIDE | Pharmacy Value Alliance, LLC | 38018e3f-3778-01d1-e054-00144ff8d46c | 2024-12-20 | Warnings | M016 |
| DiaperRashOintment | ZINC OXIDE | Pharmacy Value Alliance, LLC | 3aace6d8-d24c-00e1-e054-00144ff8d46c | 2024-12-20 | Warnings | M016 |
| Medicated Body Powder | MENTHOL | New Pride Corp | f0f0e332-cb93-42a7-e053-2995a90ac4ae | 2024-12-19 | Warnings | M016 |
| Health Smart Medicated Body | MENTHOL AND ZINC OXIDE | International Wholesale Inc dba Home Smart Products | 044870e2-ebac-a095-e063-6294a90a2751 | 2024-12-19 | Warnings | M016 |
| White Rain Original Petroleum | WHITE PETROLEUM | INTERNATIONAL WHOLESALE INC. | d6ebe00c-b692-5171-e053-2a95a90a976c | 2024-12-19 | Warnings | M016 |
| Health Smart Original Petroleum | WHITE PETROLEUM | Home Smart Products | aedf746f-4c49-421d-a666-1ba02e8fb17d | 2024-12-19 | Warnings | M016 |
| white rain Cocoa Butter Petroleum Jelly | WHITE PETROLATUM | INTERNATIONAL WHOLESALE INC. | d7068e2b-c3b2-d16d-e053-2a95a90a6dd2 | 2024-12-19 | Warnings | M016 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53329-072-16 | 53329007216 | 5 g in 1 PACKET (53329-072-16) | 5 g | 2007-01-01 | 0000-00-00 | No | No | Current |
| 53329-072-96 | 53329007296 | 144 PACKET in 1 CARTON (53329-072-96) > 5 g in 1 PACKET (53329-072-16) | 144 packet | 2007-01-01 | 0000-00-00 | No | No | Current |