Cocoa Butter

Product NDC
33992-1108
11-digit product format
339921108
Labeler code
33992
Product ID
33992-1108_abe4d54d-b026-45d0-beda-2f36ffa0c4bd
Type
HUMAN OTC DRUG
Nonproprietary name
Petrolatum
Dosage form
LOTION
Route
TOPICAL
Labeler
GREENBRIER INTERNATIONAL
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-08-02
Marketing end
0000-00-00
Substance
PETROLATUM
Active strength
5 g/100g
NDC exclude flag
E
Listing certified through
2018-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct33992-1108IInactivated by FDA2026-10-05
excluded packagepackage33992-110833992-1108-1IInactivated 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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage33992-1108-1IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33992-1108-1IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33992-1108-1IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33992-1108-1IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33992-1108-1IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage33992-1108-1IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage33992-1108-1IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage33992-1108-1IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage33992-1108-1IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage33992-1108-1IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage33992-1108-1IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage33992-1108-1IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage33992-1108-1IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage33992-1108-1IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage33992-1108-1IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage33992-1108-1IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage33992-1108-1IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage33992-1108-1IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage33992-1108-1IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage33992-1108-1IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage33992-1108-1IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage33992-1108-1EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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
33992-1108-12020-01-31C16284748780-19d75b9cf-ffd7-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33992-1108-1Cocoa Butter396.9 g in 1 BOTTLE, PLASTICLOTION396.91

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
petrolatumACTIVE INGREDIENT4T6H12BN9UCOCOA BUTTER (PETROLATUM ) LOTION [GREENBRIER INTERNATIONAL]1
petrolatumACTIVE MOIETY4T6H12BN9UCOCOA BUTTER (PETROLATUM ) LOTION [GREENBRIER INTERNATIONAL]1
cetyl alcoholINACTIVE INGREDIENT936JST6JCNCOCOA BUTTER (PETROLATUM ) LOTION [GREENBRIER INTERNATIONAL]1
cocoa butterINACTIVE INGREDIENT512OYT1CRRCOCOA BUTTER (PETROLATUM ) LOTION [GREENBRIER INTERNATIONAL]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LCOCOA BUTTER (PETROLATUM ) LOTION [GREENBRIER INTERNATIONAL]1
dimethiconeINACTIVE INGREDIENT92RU3N3Y1OCOCOA BUTTER (PETROLATUM ) LOTION [GREENBRIER INTERNATIONAL]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCOCOA BUTTER (PETROLATUM ) LOTION [GREENBRIER INTERNATIONAL]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MCOCOA BUTTER (PETROLATUM ) LOTION [GREENBRIER INTERNATIONAL]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8COCOA BUTTER (PETROLATUM ) LOTION [GREENBRIER INTERNATIONAL]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXCOCOA BUTTER (PETROLATUM ) LOTION [GREENBRIER INTERNATIONAL]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4COCOA BUTTER (PETROLATUM ) LOTION [GREENBRIER INTERNATIONAL]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TCOCOA BUTTER (PETROLATUM ) LOTION [GREENBRIER INTERNATIONAL]1
mineral oilINACTIVE INGREDIENTT5L8T28FGPCOCOA BUTTER (PETROLATUM ) LOTION [GREENBRIER INTERNATIONAL]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3COCOA BUTTER (PETROLATUM ) LOTION [GREENBRIER INTERNATIONAL]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHCOCOA BUTTER (PETROLATUM ) LOTION [GREENBRIER INTERNATIONAL]1
steareth-30INACTIVE INGREDIENT5776GCL1DGCOCOA BUTTER (PETROLATUM ) LOTION [GREENBRIER INTERNATIONAL]1
waterINACTIVE INGREDIENT059QF0KO0RCOCOA BUTTER (PETROLATUM ) LOTION [GREENBRIER INTERNATIONAL]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33992-1108COCOA BUTTER (PETROLATUM ) LOTION [GREENBRIER INTERNATIONAL]1Legacy NDC, 1 package rows20110805_577d47c9-4a40-4994-9b62-974166375183.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
33992-1108-133992110801396.9 g in 1 BOTTLE, PLASTIC396.9 gHistorical