Boogie Bottoms

Product NDC
79747-003
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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage79747-003-01fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage79747-003-0186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage79747-003-01bd6a592717d7…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

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Boogie Bottoms No-Rub Diaper RashDIMETHICONE AND ZINC OXIDEELEEO BRANDS LLCae5eedf3-86c2-69bd-e053-2995a90a43e52024-03-02WarningsExact identifier
ndc (product): 79747-003

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