FDA.reportPublic FDA data

Zinc Oxide

Product NDC
67777-223
11-digit product format
677770223
Labeler code
67777
Product ID
67777-223_4f5b6507-0292-edc3-e063-6294a90a3c79
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide Ointment
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Dynarex Corporation
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-02-29
Substance
ZINC OXIDE
Active strength
200 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE200 mg/g

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
11d79dd6-35f7-4399-e063-6294a90ac7ddAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-223-01Zinc Oxide28.4 g in 1 TUBEOINTMENT28.42
67777-223-02Zinc Oxide72 in 1 CASEOINTMENT722
67777-223-03Zinc Oxide56.7 g in 1 TUBEOINTMENT56.72
67777-223-04Zinc Oxide72 in 1 CASEOINTMENT722
67777-223-05Zinc Oxide425 g in 1 JAROINTMENT4252
67777-223-06Zinc Oxide12 in 1 CASEOINTMENT122
67777-223-11Zinc Oxide1 in 1 BOXOINTMENT12
67777-223-13Zinc Oxide1 in 1 BOXOINTMENT12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67777-223-02GM - Gram67777-223a1aba020-1f07-40bb-8d4d-dacb4126d9c912025-02-10
67777-223-04GM - Gram67777-2239b55a253-7da3-4029-ab9a-2dfba1170e1512025-02-10
67777-223-11GM - Gram67777-2235155c86f-1630-4ac9-b36b-9c3b9aaf67f712025-02-10
67777-223-13GM - Gram67777-2238f27eee2-84fa-4b25-8b80-9b847af3237c12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-223ZINC OXIDE (ZINC OXIDE OINTMENT) OINTMENT [DYNAREX CORPORATION]1Current NDC, 8 package rows20240229_11d79dd6-35f7-4399-e063-6294a90ac7dd.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 OintmentPSN11d79dd6-35f7-4399-e063-6294a90ac7dd2
198911zinc oxide 0.2 MG/MG Topical OintmentSCD11d79dd6-35f7-4399-e063-6294a90ac7dd2
198911zinc oxide 20 % Topical OintmentSY11d79dd6-35f7-4399-e063-6294a90ac7dd2
198911zinc oxide 200 MG per GM Topical OintmentSY11d79dd6-35f7-4399-e063-6294a90ac7dd2
198911ZNO 0.2 MG/MG Topical OintmentSY11d79dd6-35f7-4399-e063-6294a90ac7dd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67777-223-016777702230128.4 g in 1 TUBE28.4 gHistorical
67777-223-026777702230272 BOX in 1 CASE (67777-223-02) / 1 TUBE in 1 BOX (67777-223-11) / 28.4 g in 1 TUBE (67777-223-01) 72 box2024-02-29NoNoCurrent
67777-223-036777702230356.7 g in 1 TUBE56.7 gHistorical
67777-223-046777702230472 BOX in 1 CASE (67777-223-04) / 1 TUBE in 1 BOX (67777-223-13) / 56.7 g in 1 TUBE (67777-223-03) 72 box2024-02-29NoNoCurrent
67777-223-0567777022305425 g in 1 JAR425 gHistorical
67777-223-066777702230612 JAR in 1 CASE (67777-223-06) / 425 g in 1 JAR (67777-223-05) 12 jar2024-02-29NoNoCurrent
67777-223-11677770223111 in 1 BOXHistorical
67777-223-13677770223131 in 1 BOXHistorical