Boogie Bottoms

Product NDC
79747-003
Requested package NDC
79747-003-01
11-digit product format
797470003
Labeler code
79747
Product ID
79747-003_ee1b943e-9150-06a9-e053-2995a90ad8ad
Type
HUMAN OTC DRUG
Nonproprietary name
Dimethicone and Zinc Oxide
Dosage form
SPRAY
Route
TOPICAL
Labeler
ELEEO BRANDS LLC
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2018-06-01
Marketing end
0000-00-00
Substance
DIMETHICONE; ZINC OXIDE
Active strength
200 mg/mL; mg/mL
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage79747-00379747-003-01IInactivated by FDAexcluded / ndc_excluded.zipfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage79747-00379747-003-01IInactivated by FDAexcluded / ndc_excluded.zip86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage79747-00379747-003-01IInactivated by FDAexcluded / ndc_excluded.zipbd6a592717d7…303034d00443…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-03-02Boogie Bottoms™
2024-01-30Boogie Bottoms™
2022-11-22Boogie Bottoms™
2022-01-28Boogie Bottoms™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79747-003-01Boogie BottomsNo-Rub Diaper Rash49 mL in 1 BOTTLESPRAY494

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79747-003BOOGIE BOTTOMS NO-RUB DIAPER RASH (DIMETHICONE AND ZINC OXIDE) SPRAY [ELEEO BRANDS LLC ]4Legacy NDC, 1 package rows20240303_ae5eedf3-86c2-69bd-e053-2995a90a43e5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
968817dimethicone 20 % / zinc oxide 25 % Topical SprayPSNae5eedf3-86c2-69bd-e053-2995a90a43e54
968817dimethicone 200 MG/ML / zinc oxide 250 MG/ML Topical SpraySCDae5eedf3-86c2-69bd-e053-2995a90a43e54
968817dimethicone 20 % / zinc oxide 25 % Topical SpraySYae5eedf3-86c2-69bd-e053-2995a90a43e54
968817dimethicone 200 MG/ML / ZNO 250 MG/ML Topical SpraySYae5eedf3-86c2-69bd-e053-2995a90a43e54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79747-003-017974700030149 mL in 1 BOTTLE (79747-003-01) 49 ml2018-06-010000-00-00NoNoCurrent