FDA.reportPublic FDA data

Healing Head to Toe

Product NDC
69366-508
11-digit product format
693660508
Labeler code
69366
Product ID
69366-508_46a62a75-7bab-e273-e063-6294a90a14ce
Type
HUMAN OTC DRUG
Nonproprietary name
Allantoin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
The Honest Company, Inc
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-03-06
Substance
ALLANTOIN
Active strength
.5 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
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
Healing Head to Toe
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALLANTOIN.5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
344S277G0ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1044541Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
dc02033f-8116-1710-e053-2995a90aff69Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69366-508-292022-08-01C16284748780-1e4f33bdf-9b9a-d8a0-e053-dadaa90a6e4eHealing Head-to-Toe Ointment
69366-508-292022-07-29C16284748780-1e4f33bdf-9b9a-d8a0-e053-dadaa90a6e4eHealing Head-to-Toe Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69366-508-29Healing Head to Toe141 g in 1 TUBEOINTMENT1416
69366-508-34Healing Head to Toe283 g in 1 JAROINTMENT2836

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69366-508HEALING HEAD TO TOE (ALLANTOIN) OINTMENT [THE HONEST COMPANY, INC]5Current NDC, Legacy NDC, 2 package rows20231207_dc02033f-8116-1710-e053-2995a90aff69.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 63 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydro GelGLYCERIN 20%Trifecta Pharmaceuticals USA LLC02e8e5d0-7844-39fe-e063-6394a90a57e12024-01-19WarningsExact identifier
application number: M016
White PetrolatumWHITE PETROLATUMSled Distribution, LLCe73a4b7a-7b27-abfc-e053-2995a90a35c22024-01-15WarningsExact identifier
application number: M016
Sunmark CaldiphenCALAMINE AND PRAMOXINE HYDROCHLORIDEStrategic Sourcing Services4f4d4c54-64b5-4e20-bed0-c7fb470b84342024-01-12WarningsExact identifier
application number: M016
EIGHT HOUR NIGHTDIMETHICONEREVLONb3b277f9-565a-636c-e053-2995a90a94d22024-01-12WarningsExact identifier
application number: M016
CeraVe Developed with Dermatologists Eczema Relief CreamyOATMEALL'Oreal USA Products Incbcf7b985-6875-4033-a412-1bb6d3afa6d82024-01-01WarningsExact identifier
application number: M016
CeraVe Developed with Dermatologists HealingPETROLATUML'Oreal USA Products Inc.1b3ad3e8-cbac-4a92-84e2-4f3ab4512d952023-12-31WarningsExact identifier
application number: M016
CeraVe Developed with Dermatologists Baby HealingPETROLATUML'Oreal USA Products Inc.fe665bbc-1172-4f59-acc6-8d5c179693b62023-12-31WarningsExact identifier
application number: M016
Quality Choice Anti-Itch ClearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEChain Drug Market Associatione3c0c46d-3d85-411d-a543-009064cdd19e2023-12-28WarningsExact identifier
application number: M016
CeraVe Developed with Dermatologists Therapeutic HandDIMETHICONEL'Oreal USA Products Inc7fe49112-4180-415c-a380-768a8d6b21852023-12-28WarningsExact identifier
application number: M016
CalaclearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEPharma Nobis, LLCe42fccc2-1b4e-e7f3-e053-2a95a90aef392023-12-26WarningsExact identifier
application number: M016
Calamine Phenolated Topical SuspensionCALAMINE AND ZINC OXIDE AND PHENOLPharma Nobis, LLCe42fbdcc-3291-7761-e053-2995a90a71722023-12-26WarningsExact identifier
application number: M016
Humco CalagesicCALAMINE AND PRAMOXINE HYDROCHLORIDEPharma Nobis, LLCe42fb807-8cb4-ed25-e053-2995a90a67802023-12-26WarningsExact identifier
application number: M016
Leader Calamine PlusZINC OXIDE LOTIONCardinal Health, 110 dba Leader81f29789-f794-1e64-e053-2a91aa0ac85e2023-12-22WarningsExact identifier
application number: M016
CVS Calamine PlusZINC OXIDECVS Pharmacyb90cd214-d44a-4458-876d-59cc0795226d2023-12-22WarningsExact identifier
application number: M016
CalamineCALAMINE 8% AND ZINC OXIDE 8%Pharma Nobis, LLCe42f0bd6-3ad3-7e07-e053-2995a90a564a2023-12-22WarningsExact identifier
application number: M016
DDM CalamineCALAMINE 8% AND ZINC OXIDE 8%Discount Drug Mart5d53685b-ca4c-35c1-e053-2a91aa0aff6e2023-12-20WarningsExact identifier
application number: M016
DDM CalagesicZINC ACETATE AND PRAMOXINE HYDROCHLORIDEDiscount Drug Mart5d537a11-049e-0a8d-e053-2a91aa0aa0c32023-12-20WarningsExact identifier
application number: M016
Health Mart CalamineCALAMINE 8% AND ZINC OXIDE 8%Strategic Sourcing Services LLC349ea07d-79bc-46f3-9d60-85b40db51bbb2023-12-20WarningsExact identifier
application number: M016
Health Mart Witch HazelWITCH HAZELStrategic Sourcing Services LLC2a1d9b27-0bd4-4475-8218-ba0f5560a9692023-12-20WarningsExact identifier
application number: M016
Quality Choice CalamineCALAMINE 8% AND ZINC OXIDE 8%Chain Drug Market Association62fe653f-e861-472b-b193-4fdd9d25de8d2023-12-20WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1044541allantoin 0.5 % Topical OintmentPSNdc02033f-8116-1710-e053-2995a90aff696
1044541allantoin 0.005 MG/MG Topical OintmentSCDdc02033f-8116-1710-e053-2995a90aff696
1044541allantoin 0.5 % Topical StickSYdc02033f-8116-1710-e053-2995a90aff696

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69366-508-2969366050829141 g in 1 TUBE (69366-508-29) 141 g2023-03-060000-00-00NoNoCurrent
69366-508-3469366050834283 g in 1 JAR (69366-508-34) 283 g2024-03-10NoNoCurrent