Allantoin

Product NDC
63940-022
11-digit product format
639400022
Labeler code
63940
Product ID
63940-022_c77cc924-17e5-09e3-e053-2995a90ad95a
Type
HUMAN OTC DRUG
Nonproprietary name
Advanced Derma Therapy
Dosage form
SPRAY
Route
TOPICAL
Labeler
Harmon Store Inc.
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-09-04
Marketing end
0000-00-00
Substance
ALLANTOIN
Active strength
0 g/85g
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63940-022DDiscontinued by firm2026-10-05
excluded packagepackage63940-02263940-022-03DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63940-022-03d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63940-022-03f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63940-022-032ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63940-022-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63940-022-03cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63940-022-03cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63940-022-03302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63940-022-03ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63940-022-030efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63940-022-03ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63940-022-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63940-022-03557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALLANTOINACTIVE INGREDIENT344S277G0ZALLANTOIN (ADVANCED DERMA THERAPY) SPRAY [HARMON STORE INC.]1
ALLANTOINACTIVE MOIETY344S277G0ZALLANTOIN (ADVANCED DERMA THERAPY) SPRAY [HARMON STORE INC.]1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RAALLANTOIN (ADVANCED DERMA THERAPY) SPRAY [HARMON STORE INC.]1
CETYL HYDROXYETHYLCELLULOSE (350000 MW)INACTIVE INGREDIENTT7SWE4S2TTALLANTOIN (ADVANCED DERMA THERAPY) SPRAY [HARMON STORE INC.]1
DIMETHYL ETHERINACTIVE INGREDIENTAM13FS69BXALLANTOIN (ADVANCED DERMA THERAPY) SPRAY [HARMON STORE INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXALLANTOIN (ADVANCED DERMA THERAPY) SPRAY [HARMON STORE INC.]1
GLYCERYL STEARATE CITRATEINACTIVE INGREDIENTWH8T92A065ALLANTOIN (ADVANCED DERMA THERAPY) SPRAY [HARMON STORE INC.]1
ISOSTEARYL ISOSTEARATEINACTIVE INGREDIENTIV0Z586Z4YALLANTOIN (ADVANCED DERMA THERAPY) SPRAY [HARMON STORE INC.]1
LIMA BEANINACTIVE INGREDIENT112YH1ZMX2ALLANTOIN (ADVANCED DERMA THERAPY) SPRAY [HARMON STORE INC.]1
ONIONINACTIVE INGREDIENT492225Q21HALLANTOIN (ADVANCED DERMA THERAPY) SPRAY [HARMON STORE INC.]1
PALMITOYL TETRAPEPTIDE-7INACTIVE INGREDIENTQ41S464P1RALLANTOIN (ADVANCED DERMA THERAPY) SPRAY [HARMON STORE INC.]1
PALMITOYL TRIPEPTIDE-1INACTIVE INGREDIENTRV743D216MALLANTOIN (ADVANCED DERMA THERAPY) SPRAY [HARMON STORE INC.]1
PENTAERYTHRITYL TETRACAPRYLATE/TETRACAPRATEINACTIVE INGREDIENT832C4KF14XALLANTOIN (ADVANCED DERMA THERAPY) SPRAY [HARMON STORE INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TALLANTOIN (ADVANCED DERMA THERAPY) SPRAY [HARMON STORE INC.]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4ALLANTOIN (ADVANCED DERMA THERAPY) SPRAY [HARMON STORE INC.]1
PPG-3 BENZYL ETHER MYRISTATEINACTIVE INGREDIENT8075L58MKOALLANTOIN (ADVANCED DERMA THERAPY) SPRAY [HARMON STORE INC.]1
RUTININACTIVE INGREDIENT5G06TVY3R7ALLANTOIN (ADVANCED DERMA THERAPY) SPRAY [HARMON STORE INC.]1
SALICYLIC ACIDINACTIVE INGREDIENTO414PZ4LPZALLANTOIN (ADVANCED DERMA THERAPY) SPRAY [HARMON STORE INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554ALLANTOIN (ADVANCED DERMA THERAPY) SPRAY [HARMON STORE INC.]1
SUCROSE PALMITATEINACTIVE INGREDIENT3OSQ643ZK5ALLANTOIN (ADVANCED DERMA THERAPY) SPRAY [HARMON STORE INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RALLANTOIN (ADVANCED DERMA THERAPY) SPRAY [HARMON STORE INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEALLANTOIN (ADVANCED DERMA THERAPY) SPRAY [HARMON STORE INC.]1
YEAST MANNANINACTIVE INGREDIENT91R887N59PALLANTOIN (ADVANCED DERMA THERAPY) SPRAY [HARMON STORE INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63940-022-036394000220385 g in 1 CAN (63940-022-03) 85 g2015-09-040000-00-00NoNoCurrent