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

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 1 of 71 · 1,410 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dermaka Infants and Kids Multi Purpose Skin ProtectantZINC OXIDEDermaka Skin Products LLCf84dfd55-db6c-4d75-be67-4d13a139e2092026-09-10WarningsExact identifier
application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic MultipurposeDIMETHICONEL'Oreal USA Products Inc805cd262-2689-4818-8fed-ddefacbdde232026-09-10WarningsExact identifier
application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Therapeutic MultipurposeDIMETHICONECosmetique Active Productiond19f482c-bec7-45aa-b22f-fe91a3dc717d2026-09-10WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDECVS Pharmacy, Inc.35e67726-4527-4cd7-8e73-30325a32402c2026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Lanolin, PetrolatumLANOLIN, PETROLATUMCVS Pharmacy, Inc.606f65a8-08fd-4ab6-9d68-03ddf662bdf02026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Eczema Soothing Moisturizing CreamCOLLOIDAL OATMEALNice-Pak Products, LLC23548524-2e2e-4d1a-9ebb-6f86d6279e932026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMWalgreen Co.22bd8e87-965c-466b-bb9b-7d4753e500bc2026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Drs. pharmacy Scar CreamALLANTOINOL PHARMA TECH, LLC Drs PHARMACYd0381034-8cf7-5e8d-e053-2995a90a9faa2026-09-09WarningsExact identifier
application number: M016
Drs. Pharmacy baby healingPETROLATUMOL PHARMA TECH, LLC Drs PHARMACY5b14ffa0-9486-a7fe-e063-6394a90ab3ed2026-09-09WarningsExact identifier
application number: M016
Wart RemoverGLYCERINShantou Ouhoe Technology Co., Ltd.5af3afe1-dad5-91b7-e063-6294a90ab95e2026-09-08WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP5afb3595-f014-153e-e063-6294a90ad34b2026-09-08WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP5afb59b4-491c-45bb-e063-6294a90a0ae62026-09-08WarningsExact identifier
application number: M016
ClaravieALUMINUM HYDROXIDE GELGentell LLC5afea757-8feb-f907-e063-6394a90a62592026-09-08WarningsExact identifier
application number: M016
Clear Anti ItchPRAMOXINE HCL, ZINC ACETATEUnited Natural Foods, Inc. dba UNFI242adc68-f9e0-4f69-a580-a107d1634b502026-09-04Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
application number: M016
FIRST AID BEAUTY FAB ULTRA REPAIR SKIN PROTECTANT KitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company5a9aaca8-474a-0393-e063-6394a90a5a3a2026-09-04WarningsExact identifier
application number: M016
Aveeno Eczema Therapy CreamCOLLOIDAL OATMEALKenvue Brands LLC5a7b0470-3ed5-5b92-e063-6294a90ae0f42026-09-03WarningsExact identifier
application number: M016
First Aid Beauty Face and Body Bestsellers KitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company5a974dbf-84ac-5374-e063-6294a90a8da02026-09-03WarningsExact identifier
application number: M016
Pure Petrolatum JellyPETROLATUMJell Pharmaceuticals Pvt. Ltd.cdc297cb-476a-6da9-e053-2a95a90a399a2026-09-02WarningsExact identifier
application number: M016
Nail Treatment LiquidGLYCERINShantou Ximonth Biotechnology Co., Ltd.5a7cd607-a50e-17d0-e063-6294a90acdb22026-09-02WarningsExact 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