FDA.reportPublic FDA data

Empower

Product NDC
83744-001
11-digit product format
837440001
Labeler code
83744
Product ID
83744-001_08006b60-966c-155b-e063-6294a90a206a
Type
HUMAN OTC DRUG
Nonproprietary name
White Petrolatum, Zinc Oxide
Dosage form
SPRAY
Route
TOPICAL
Labeler
Bemis Manufacturing Company Inc
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-18
Substance
WHITE PETROLATUM; ZINC OXIDE
Active strength
30; 10 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Empower
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WHITE PETROLATUM30 g/100g
ZINC OXIDE10 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
B6E5W8RQJ4Internal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2667940Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
08006b60-966b-155b-e063-6294a90a206aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83744-001-40Empower40 g in 1 BOTTLE, SPRAYSPRAY401

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83744-001EMPOWER (WHITE PETROLATUM, ZINC OXIDE) SPRAY [BEMIS MANUFACTURING COMPANY INC]1Current NDC, 1 package rows20231019_08006b60-966b-155b-e063-6294a90a206a.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 68 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anubis Barcelona New EvenLACTIC ACID, CITRIC ACID, GLYCOLIC ACIDANUBIS COSMETICS SLeaeeb6e0-5322-20c4-e053-2995a90a9fd92023-09-01WarningsExact identifier
application number: M016
Anubis Barcelona Vital LineHYDROLYZED COLLAGENANUBIS COSMETICS SLf564bbf0-3b5c-4a81-e053-2a95a90a7ea62023-08-29WarningsExact identifier
application number: M016
Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen SPF 15CAMPHOR (SYNTHETIC), PETROLATUMCarma Laboratories, Inc.5378d653-702d-405c-a067-882554aaf93a2023-08-21WarningsExact identifier
application number: M016
Quality Choice Anti-itch MedicatedCALAMINE AND PRAMOXINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INC5e07f26f-cfb6-57f9-e053-2991aa0a20082023-08-02WarningsExact identifier
application number: M016
Barrier BalmBARRIER BALMAutumn Harp, Inc.01df9746-991b-4363-e063-6294a90aaac62023-08-01WarningsExact identifier
application number: M016
Barrier CreamZINC OXIDEAvasol LLCbc6a2736-faa6-46d3-af9b-a70f0762e9ce2023-05-15WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Candy CaneCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Companybec2f702-5ff5-ea66-e053-2a95a90ad1ec2023-01-01WarningsExact identifier
application number: M016
Badger After-BUG BalmCOLLOIDAL OATMEALW.S. Badger Company, Inc.a623da47-cef2-146f-e053-2a95a90afe3a2021-11-17WarningsExact identifier
application number: M016
Derma-e Eczema ReliefOATMEALTopiderm, Ince1797f81-af4b-49e1-9906-dbfd904a282b2020-08-19WarningsExact identifier
application number: M016
Resurfix PlusPETROLATUMTopiderm, Inc.f100f43d-6ace-4c3a-9c85-640c0ab2e3602019-11-19WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2667940petrolatum 30 % / zinc oxide 10 % Topical SprayPSN08006b60-966b-155b-e063-6294a90a206a1
2667940petrolatum 300 MG/ML / zinc oxide 100 MG/ML Topical SpraySCD08006b60-966b-155b-e063-6294a90a206a1
2667940petrolatum 30 % / zinc oxide 10 % Topical SpraySY08006b60-966b-155b-e063-6294a90a206a1
2667940petrolatum 300 MG/ML / ZNO 100 MG/ML Topical SpraySY08006b60-966b-155b-e063-6294a90a206a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83744-001-408374400014040 g in 1 BOTTLE, SPRAY (83744-001-40) 40 g2023-10-18NoNoCurrent