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 17 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clear Anti-ItchPRAMOXINE HCL, ZINC ACETATEOld East Main Co.91df1434-bce6-4c6e-beee-cb5ec1cc8fff2026-03-02Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMOld East Main Co.cf916191-1de2-4305-b783-9e074c1ad94b2026-03-02Warnings, Adverse reactionsExact identifier
application number: M016
Eczema ReliefCOLLOIDAL OATMEALOld East Main Co.b2dba027-c295-4a41-8d30-144904e1aa342026-03-02Warnings, Adverse reactionsExact identifier
application number: M016
Baby Eczema TherapyCOLLOIDAL OATMEALOld East Main Co.9720e2ad-1bcf-4023-8e92-22a962df3aad2026-03-02Warnings, Adverse reactionsExact identifier
application number: M016
CalamineFERRIC OXIDE REDChain Drug Marketing Association86ff4875-9007-4b7b-8f46-16cbd475d4bb2026-02-27Warnings, Adverse reactionsExact identifier
application number: M016
Clear Anti-ItchPRAMOXINE HCL, ZINC ACETATEChain Drug Marketing Association1ff6bd85-3658-47ea-b6ca-0eb5d8dbb6932026-02-27Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINE, PRAMOXINE HCLChain Drug Marketing Association6c848b98-f01c-40f2-a9aa-2af76cb370c82026-02-27Warnings, Adverse reactionsExact identifier
application number: M016
Diaper RashZINC OXIDEThe Kroger Co.fcffbe1f-79b8-451a-9384-19533b81d8c82026-02-27Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMThe Kroger Co.d2095c7b-61ca-40d3-bbf1-04bed4dd789c2026-02-27Warnings, Adverse reactionsExact identifier
application number: M016
Daily MoisturizingDIMETHICONEThe Kroger Co.ea8b186c-82d5-4552-bcce-03e56023ea992026-02-27Warnings, Adverse reactionsExact identifier
application number: M016
Diaper Rash CreamZINC OXIDESmalls Brand LLC DBA Roe Wellness4bd29285-29b4-5d57-e063-6294a90af4812026-02-27WarningsExact identifier
application number: M016
Vitamin A DLANOLIN, PETROLATUMWalmart Inc.5893801a-25e1-4750-a55b-d9cddd3f12842026-02-27Warnings, Adverse reactionsExact identifier
application number: M016
Diaper RashZINC OXIDEWalmart Inc.320bcbd3-9e91-437f-99c5-066f880a4b322026-02-27Warnings, Adverse reactionsExact identifier
application number: M016
Skin ProtectantPETROLATUMWalmart Inc.eb836922-f467-42ab-a6e7-b787d97e6c172026-02-27Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMWalmart Inc.aa7dbf7f-50be-475b-8140-68be3fa935072026-02-27Warnings, Adverse reactionsExact identifier
application number: M016
White PetrolatumWHITE PETROLATUMWalmart Inc.176d7711-7c4f-4319-91af-0aba1260c4122026-02-27Warnings, Adverse reactionsExact identifier
application number: M016
Soothing MoisturizingCOLLOIDAL OATMEALWalmart Inc.2d813455-c268-4c6d-9952-eaf0e0007d902026-02-27Warnings, Adverse reactionsExact identifier
application number: M016
Rapid Repair Healing CreamALLANTOIN, DIMETHICONEJune Jacobs Labs LLC186c13be-5e41-b9c9-e063-6294a90ad5742026-02-26WarningsExact identifier
application number: M016
LanashieldLANOLINDynarex Corporation94b277dc-6512-4d36-8485-8ea5100974282026-02-26WarningsExact identifier
application number: M016
GLADSKIN ECZEMACT ECZEMACOLLOIDAL OATMEALMicreos North America, Inc.06f9af75-c5ff-d37b-e063-6394a90a4f6c2026-02-25WarningsExact 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