FDA.reportPublic FDA data

Cremo All-Season Lip Balm SPF 25 Vanilla Mint

Product NDC
71825-120
Requested package NDC
71825-120-61
11-digit product format
718250120
Labeler code
71825
Product ID
71825-120_d4ec08df-8f37-8e0d-e053-2a95a90af728
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene, Petrolatum
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Cremo Company
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2022-01-06
Marketing end
0000-00-00
Substance
AVOBENZONE; OCTISALATE; HOMOSALATE; PETROLATUM; OCTOCRYLENE
Active strength
3 g/1000g; g/1000g; g/1000g; g/1000g; g/1000g
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.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage71825-12071825-120-61IInactivated by FDA2026-10-05

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.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71825-120-612025-01-30C16284748780-12cef2736-64ed-d83d-e063-dadaa90ab31fLip Balm SPF 25 Vanilla Mint

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71825-120-61Cremo All-Season Lip Balm SPF 25 Vanilla Mint7 g in 1 TUBEOINTMENT71

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71825-120CREMO ALL-SEASON LIP BALM SPF 25 VANILLA MINT (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, PETROLATUM) OINTMENT [CREMO COMPANY]1Legacy NDC, 1 package rows20220107_d4ec08df-8f36-8e0d-e053-2a95a90af728.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71825-120-61718250120617 g in 1 TUBE (71825-120-61) 7 g2022-01-060000-00-00NoNoCurrent