FDA.reportPublic FDA data

Triple Diaper Rash

Product NDC
16864-021
11-digit product format
168640021
Labeler code
16864
Product ID
16864-021_4d63f2a2-f114-d739-e063-6394a90a2d27
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Advantice Health, LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-05-15
Substance
ZINC OXIDE
Active strength
12.8 g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
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
Triple Diaper Rash
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE12.8 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
637168Internal RxNorm lookup
729935Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d457c58d-8239-41c4-999e-d0ba237e3945Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16864-021-01Triple Diaper Rash1 in 1 CARTONOINTMENT16
16864-021-01Triple Diaper Rash57 g in 1 TUBEOINTMENT576
16864-021-02Triple Diaper Rash1 in 1 CARTONOINTMENT16
16864-021-02Triple Diaper Rash85 g in 1 TUBEOINTMENT856
16864-021-03Triple Diaper Rash227 g in 1 JAROINTMENT2276
16864-021-04Triple Diaper Rash283 g in 1 JAROINTMENT2836
16864-021-05Triple Diaper Rash454 g in 1 JAROINTMENT4546
16864-021-06Triple Diaper Rash1 in 1 CARTONOINTMENT16
16864-021-06Triple Diaper Rash11.5 g in 1 TUBEOINTMENT11.56
16864-021-07Triple Diaper Rash6 g in 1 PACKETOINTMENT66

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16864-021-01GM - Gram16864-021e8c9a740-660a-4885-a286-109a7717932c12023-01-09
16864-021-05GM - Gram16864-0210eed86da-4c82-4c0d-920f-7271d41a854212023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16864-021TRIPLE DIAPER RASH (ZINC OXIDE) OINTMENT [ADVANTICE HEALTH, LLC]5Current NDC, Legacy NDC, 10 package rows20241011_d457c58d-8239-41c4-999e-d0ba237e3945.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 36 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JAFRA Fruteria Coco Fresco Lip BalmDIMETHICONEDistribuidora Comercial Jafra, S.A. de C.V.9895a320-8a74-4b27-9bf1-4b492f89888c2025-10-21WarningsExact identifier
application number: M016
JAFRA Fruteria So CitricoDIMETHICONEDistribuidora Comercial Jafra, S.A. de C.V.a68d6cda-2268-440a-9ca6-677c4e3ea0e72025-10-21WarningsExact identifier
application number: M016
JAFRA Fruteria Very Verde Lip BalmDIMETHICONEDistribuidora Comercial Jafra, S.A. de C.V.4f0de70b-7ebe-4381-9b46-d5b334f426e02025-10-21WarningsExact identifier
application number: M016
Gelmicin Hydrocortisone with AloeHYDROCORTISONEUnited Exchange Corp.bb64eca4-799d-4711-e053-2995a90af4032025-10-21WarningsExact identifier
application number: M016
QuadrydernHYDROCORTISONEProductos Zapotol Corpa087ad4d-9a65-19c3-e053-2995a90ab3412025-10-21WarningsExact identifier
application number: M016
VENROCKROSEMARY OILGuangzhou Oupeng Cosmetics Co., Ltd4156b669-1817-6280-e063-6394a90aaf3a2025-10-17WarningsExact identifier
application number: M016
Gerigentle-Vitamins A and DPETROLATUMGeri-Gentle Corporationc36c74f7-975b-4e4c-99e3-e6921d782c712025-10-17WarningsExact identifier
application number: M016
Seacall Dexamethasone Ointment.DEXAMETHASONE OINTMENTGuangdong Quadrant Ecological Technology Co., Ltd.201adf67-773c-34a2-e063-6394a90ac5252025-10-15WarningsExact identifier
application number: M016
MedlineZINC OXIDEMedline Industries, LPdae45414-7401-9536-e053-2a95a90a0a862025-10-15WarningsExact identifier
application number: M016
Curology Barrier BalmSKIN BARRIER BALMCurology04b2ba38-0f81-be51-e063-6294a90af8212025-10-15WarningsExact identifier
application number: M016
PetroleumWHITE PETROLATUMMedline Industries, LP34f3581f-39ba-4f28-9237-52f3820ab4c02025-10-09WarningsExact identifier
application number: M016
Facial FortressPYRITHIONE ZINCPediatric Solutions, LLCcdd3c52e-4c32-46c1-bdb3-957b164190bb2025-10-08WarningsExact identifier
application number: M016
Happy CappyPYRITHIONE ZINCPediatric Solutions, LLC3d3828d8-ee15-4aff-99d1-a121f0102a002025-10-08WarningsExact identifier
application number: M016
Purforma Advanced Hand Sanitizer 70% AlcoholHAND SANITIZER 70% ALCOHOLSpartan Chemical Company, Inc.06bd825d-914f-5ca7-e063-6394a90aec492025-10-06WarningsExact identifier
application number: M016
Scar Reducer Intensive Herbal and NutrientALLANTOINQuantum, Inc5197f1fa-aae5-406c-97d9-635b8c1a88a82025-10-06WarningsExact identifier
application number: M016
PURE SOL SPF 30 LIP BALM CACOA BUTTERZINC OXIDEBrand 2022b LLC40537561-d334-5859-e063-6394a90a92a72025-10-04WarningsExact identifier
application number: M016
PURE SOL SPF15 Lip Gloss originalZINC OXIDEBrand 2022b LLC4056e49a-2976-38f9-e063-6394a90a786d2025-10-04WarningsExact identifier
application number: M016
PURE SOL SPF15 Lip Gloss Nudie roseZINC OXIDEBrand 2022b LLC4057b0e2-1c31-abae-e063-6294a90a053d2025-10-04WarningsExact identifier
application number: M016
PURE SOL SPF15 Lip Gloss Pink coralZINC OXIDEBrand 2022b LLC405865dd-7d0e-048d-e063-6394a90ab1052025-10-04WarningsExact identifier
application number: M016
HealthWise Medicated Diabetic Foot CreamDIMETHICONE, PETROLATUMVeridian Healthcare164f4cd8-975a-40d5-e063-6394a90ae7d52025-10-02WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
729935TRIPLE PASTE 12.8 % Topical OintmentPSNd457c58d-8239-41c4-999e-d0ba237e39456
637168zinc oxide 12.8 % Topical OintmentPSNd457c58d-8239-41c4-999e-d0ba237e39456
729935zinc oxide 0.128 MG/MG Topical Ointment [Triple Paste]SBDd457c58d-8239-41c4-999e-d0ba237e39456
637168zinc oxide 0.128 MG/MG Topical OintmentSCDd457c58d-8239-41c4-999e-d0ba237e39456
729935Triple Paste 0.128 MG/MG Topical OintmentSYd457c58d-8239-41c4-999e-d0ba237e39456
729935Triple Paste 12.8 % Topical OintmentSYd457c58d-8239-41c4-999e-d0ba237e39456
637168zinc oxide 12.8 % Topical OintmentSYd457c58d-8239-41c4-999e-d0ba237e39456
637168ZNO 0.128 MG/MG Topical OintmentSYd457c58d-8239-41c4-999e-d0ba237e39456
729935ZNO 0.128 MG/MG Topical Ointment [Triple Paste]SYd457c58d-8239-41c4-999e-d0ba237e39456

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16864-021-01168640021011 TUBE in 1 CARTON (16864-021-01) / 57 g in 1 TUBE1 tube2021-05-150000-00-00NoNoCurrent
16864-021-02168640021021 TUBE in 1 CARTON (16864-021-02) / 85 g in 1 TUBE1 tube2021-05-150000-00-00NoNoCurrent
16864-021-0316864002103227 g in 1 JAR (16864-021-03) 227 g2021-05-150000-00-00NoNoCurrent
16864-021-0416864002104283 g in 1 JAR (16864-021-04) 283 g2021-05-150000-00-00NoNoCurrent
16864-021-0516864002105454 g in 1 JAR (16864-021-05) 454 g2021-05-150000-00-00NoNoCurrent
16864-021-06168640021061 TUBE in 1 CARTON (16864-021-06) / 11.5 g in 1 TUBE1 tube2021-05-150000-00-00NoNoCurrent
16864-021-07168640021076 g in 1 PACKET (16864-021-07) 6 g2024-05-01YesNoCurrent