FDA.reportPublic FDA data

Medpura Zinc Oxide 20%

Product NDC
71399-0245
11-digit product format
713990245
Labeler code
71399
Product ID
71399-0245_4861cc3a-ca26-82e8-e063-6294a90a1bff
Type
HUMAN OTC DRUG
Nonproprietary name
Medpura Zinc Oxide 20%
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Akron Pharma Inc.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-09-13
Substance
ZINC OXIDE
Active strength
20 g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Medpura Zinc Oxide 20%
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE20 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198911Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3a63aaea-087e-4115-8478-64d416e6085fAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71399-0245-2Medpura Zinc Oxide 20%1 in 1 CARTONOINTMENT15
71399-0245-2Medpura Zinc Oxide 20%56.7 g in 1 TUBEOINTMENT56.75
71399-0245-3Medpura Zinc Oxide 20%85 g in 1 TUBEOINTMENT855
71399-0245-3Medpura Zinc Oxide 20%1 in 1 CARTONOINTMENT15
71399-0245-6Medpura Zinc Oxide 20%454 g in 1 JAROINTMENT4545

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-0245-2GM - Gram71399-02452ea9c133-b71e-45b1-9261-eb5c2aab6d9012022-12-07
71399-0245-3GM - Gram71399-0245cd20344b-dd97-4472-b7d9-4919a09bcb8f12022-01-06
71399-0245-6GM - Gram71399-0245c7b7b919-77a4-4ce4-b13e-6bc3edc8e0ba12021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71399-0245MEDPURA ZINC OXIDE 20% OINTMENT [AKRON PHARMA INC.]4Current NDC, Legacy NDC, 5 package rows20240920_3a63aaea-087e-4115-8478-64d416e6085f.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 70 · 1,385 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hair Regrowth FoamGLYCERINShantou Ouhoe Technology Co., Ltd.59ef5953-e96f-5707-e063-6294a90a30942026-08-26WarningsExact identifier
application number: M016
Acne ReliefSALICYLIC ACID,NIACINAMIDE,PANTHENOL.Guangzhou Senmai Biotechnology Co.,Ltd.59db0143-de57-59d2-e063-6294a90a32a82026-08-25WarningsExact identifier
application number: M016
Witch HazelWITCH HAZELYour Military Exchanges4079fd56-55f3-4e69-93e0-7590c07fb7942026-08-25Warnings, Adverse reactionsExact identifier
application number: M016
Salicylic Acid Acne Gel CleanserSALICYLIC ACID,PANTHENOLGuangzhou Senmai Biotechnology Co.,Ltd.59eb395b-493b-efc9-e063-6294a90aa8912026-08-25WarningsExact identifier
application number: M016
ClaravieDIMETHICONEGentell LLC59c6da39-b5f1-8253-e063-6394a90a0e8f2026-08-24WarningsExact identifier
application number: M016
MUSTELA Diaper Rash 1 2 3ZINC OXIDEExpanscience Laboratories d/b/a Mustela59cf1d1e-e951-9d58-e063-6394a90af0f32026-08-24WarningsExact identifier
application number: M016
ClaravieZINC OXIDE, DIMETHICONEGentell LLC598a5c0b-1e2f-1335-e063-6394a90ac4f42026-08-21WarningsExact identifier
application number: M016
MUSTELA Diaper Rash 1 2 3ZINC OXIDEExpanscience Laboratories d/b/a Mustela163f388e-849d-4b7e-93c1-9045d77a9ec22026-08-21WarningsExact identifier
application number: M016
MedlineWHITE PETROLATUM, ZINC OXIDEMedline Industries, LP0073de92-585d-e01a-e063-6394a90a2ec22026-08-21WarningsExact identifier
application number: M016
Mederma PMDIMETHICONEL Perrigo Company8c728904-28f4-4333-a9ea-20996fd1b0072026-08-21WarningsExact identifier
application number: M016
Earths Care Hemorrhoid ReliefWITCH HAZEL AND MENTHOL, UNSPECIFIED FORMDLC Laboratories, Inc.e860d65b-126d-4d77-8003-9d1381849ab52026-08-20WarningsExact identifier
application number: M016
ClaraViePETROLATUMGentell LLC596987e4-4205-b911-e063-6294a90aa5702026-08-19WarningsExact identifier
application number: M016
ClaraVieZINC OXIDEGentell LLC596abd98-17d7-2a22-e063-6294a90af57d2026-08-19WarningsExact identifier
application number: M016
Claravie Skin Repair CreamDIMETHICONEGentell LLC596ae269-172e-aef5-e063-6394a90a4e2a2026-08-19WarningsExact identifier
application number: M016
ClaravieLANOLINGentell LLC596c1b73-e34d-c97d-e063-6394a90ada1b2026-08-19WarningsExact identifier
application number: M016
ClaraVieMENTHOL, ZINC OXIDEGentell LLC596c467f-a056-ea78-e063-6394a90a79f22026-08-19WarningsExact identifier
application number: M016
ClaraVieLANOLINGentell LLC596fe32d-be34-0635-e063-6394a90a2fc02026-08-19WarningsExact identifier
application number: M016
MedprideZINC OXIDEShield Line LLCe2689cae-e347-4c0b-825b-6281a0b7c2f12026-08-18WarningsExact identifier
application number: M016
Eczema Skin Relief CreamCOLLOIDAL OATMEALCVS Health98fac854-f7b0-4c6e-888d-1bdc6b9323b92026-08-17WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDEADUSA Distribution, LLC5940399c-31e3-6d51-e063-6294a90a8e7c2026-08-17Warnings, Adverse reactionsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198911zinc oxide 20 % Topical OintmentPSN3a63aaea-087e-4115-8478-64d416e6085f5
198911zinc oxide 0.2 MG/MG Topical OintmentSCD3a63aaea-087e-4115-8478-64d416e6085f5
198911zinc oxide 20 % Topical OintmentSY3a63aaea-087e-4115-8478-64d416e6085f5
198911zinc oxide 200 MG per GM Topical OintmentSY3a63aaea-087e-4115-8478-64d416e6085f5
198911ZNO 0.2 MG/MG Topical OintmentSY3a63aaea-087e-4115-8478-64d416e6085f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71399-0245-2713990245021 TUBE in 1 CARTON (71399-0245-2) / 56.7 g in 1 TUBE1 tube2024-09-130000-00-00NoNoCurrent
71399-0245-3713990245031 TUBE in 1 CARTON (71399-0245-3) / 85 g in 1 TUBE1 tube2024-09-130000-00-00NoNoCurrent
71399-0245-671399024506454 g in 1 JAR (71399-0245-6) 454 g2024-09-130000-00-00NoNoCurrent