FDA.reportPublic FDA data

Safety 1st Oh Sh t Kit

Product NDC
50428-0033
11-digit product format
504280033
Labeler code
50428
Product ID
50428-0033_47f562ce-f3cd-8889-e063-6394a90ad950
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
KIT
Labeler
Dorel Juvenile Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-07-01
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Safety 1st Oh Sh t Kit
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
247835Internal RxNorm lookup
581660Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b142009c-8276-e2fd-e053-2a95a90aad16Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50428-0032-5Safety 1st Oh Sh t Kit5 mL in 1 POUCHGEL5 mL0.62 mL in 1mL3
50428-0033-1Safety 1st Oh Sh t Kit1 in 1 KITKIT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50428-0033SAFETY 1ST OH SH T KIT (ALCOHOL) KIT [DOREL JUVENILE INC.]2Current NDC, Legacy NDC, 2 package rows20231024_b142009c-8276-e2fd-e053-2a95a90aad16.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
Safety 1st Oh Sh t KitALCOHOLDorel Juvenile Inc.b142009c-8276-e2fd-e053-2a95a90aad162026-01-09WarningsExact identifier
ndc (product): 50428-0033

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581660ethanol 62 % Topical GelPSNb142009c-8276-e2fd-e053-2a95a90aad163
247835ethanol 62 % Topical SolutionPSNb142009c-8276-e2fd-e053-2a95a90aad163
581660ethanol 0.62 ML/ML Topical GelSCDb142009c-8276-e2fd-e053-2a95a90aad163
247835ethanol 0.62 ML/ML Topical SolutionSCDb142009c-8276-e2fd-e053-2a95a90aad163
581660ethanol 62 % Topical GelSYb142009c-8276-e2fd-e053-2a95a90aad163
247835ethanol 62 % Topical SolutionSYb142009c-8276-e2fd-e053-2a95a90aad163
247835ethyl alcohol 62 % Topical SolutionSYb142009c-8276-e2fd-e053-2a95a90aad163

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50428-0032-5504280032055 mL in 1 POUCH5 mlHistorical
50428-0033-1504280033011 KIT in 1 KIT (50428-0033-1) * 5 mL in 1 POUCH (50428-0032-5) 1 kit2020-07-010000-00-00NoNoCurrent