FDA.reportPublic FDA data

Aluroderm Scar

Product NDC
84991-0316
11-digit product format
849910316
Labeler code
84991
Product ID
84991-0316_2d94d970-563c-466c-e063-6294a90a93db
Type
HUMAN OTC DRUG
Nonproprietary name
allantoin
Dosage form
PATCH
Route
CUTANEOUS
Labeler
Olakino Therapeutics LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-24
Substance
ALLANTOIN
Active strength
.0075 g/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Aluroderm Scar
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALLANTOIN.0075 g/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii344S277G0Z
Rxcui2711688

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84991-0316-1Aluroderm Scar5 in 1 POUCHPATCH52
84991-0316-1Aluroderm Scar1 in 1 BOXPATCH12
84991-0316-5Aluroderm Scar5 in 1 POUCHPATCH52
84991-0316-5Aluroderm Scar8.5 g in 1 PATCHPATCH8.52

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
84991-0316-1EA - Each84991-0316b16dde49-d6b5-4fb3-b54d-a484f7ce4e6212025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84991-0316ALURODERM SCAR (ALLANTOIN) PATCH [OLAKINO THERAPEUTICS LLC]2Current NDC, 4 package rows20250210_2a848dde-8fc4-ab10-e063-6294a90a2583.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2711688allantoin 0.75 % Medicated PatchPSN2a848dde-8fc4-ab10-e063-6294a90a25832
2711688allantoin 0.0075 MG/MG Medicated PatchSCD2a848dde-8fc4-ab10-e063-6294a90a25832
2711688allantoin 0.75 % Medicated PatchSY2a848dde-8fc4-ab10-e063-6294a90a25832
2711688allantoin 0.75 % Medicated PatchPSN60656ca1-5218-4595-854e-19f1061def1e1
2711688allantoin 0.0075 MG/MG Medicated PatchSCD60656ca1-5218-4595-854e-19f1061def1e1
2711688allantoin 0.75 % Medicated PatchSY60656ca1-5218-4595-854e-19f1061def1e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84991-0316-1849910316011 POUCH in 1 BOX (84991-0316-1) / 5 PATCH in 1 POUCH / 8.5 g in 1 PATCH1 pouch2024-12-24NoNoCurrent
84991-0316-5849910316055 PATCH in 1 POUCH (84991-0316-5) / 8.5 g in 1 PATCH5 patch2024-12-24NoNoCurrent