FDA.reportPublic FDA data

COATS ALOE

Product NDC
70211-705
Requested package NDC
70211-705-08
11-digit product format
702110705
Labeler code
70211
Product ID
70211-705_f18f3ef4-76c0-33a5-e053-2995a90aeba4
Type
HUMAN OTC DRUG
Nonproprietary name
ALLANTOIN
Dosage form
JELLY
Route
TOPICAL
Labeler
TYCHASIS CORPORATION
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-11-02
Marketing end
0000-00-00
Substance
ALLANTOIN
Active strength
1 g/100mL
NDC exclude flag
No
Listing certified through
2024-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70211-70570211-705-08IInactivated by FDA2026-10-05

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage70211-70570211-705-08EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70211-705-08COATS ALOE237 mL in 1 BOTTLE, DISPENSINGJELLY2374

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70211-705-08ML - Milliliter70211-70565691cf3-12de-490f-932f-ab6d9f988d7c12016-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALLANTOINACTIVE INGREDIENT344S277G0ZCOATS ALOE (ALLANTOIN) JELLY [TYCHASIS CORPORATION]1
ALLANTOINACTIVE MOIETY344S277G0ZCOATS ALOE (ALLANTOIN) JELLY [TYCHASIS CORPORATION]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XCOATS ALOE (ALLANTOIN) JELLY [TYCHASIS CORPORATION]1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RACOATS ALOE (ALLANTOIN) JELLY [TYCHASIS CORPORATION]1
CHLORPHENESININACTIVE INGREDIENTI670DAL4SZCOATS ALOE (ALLANTOIN) JELLY [TYCHASIS CORPORATION]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCOATS ALOE (ALLANTOIN) JELLY [TYCHASIS CORPORATION]1
PANTHENOLINACTIVE INGREDIENTWV9CM0O67ZCOATS ALOE (ALLANTOIN) JELLY [TYCHASIS CORPORATION]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4COATS ALOE (ALLANTOIN) JELLY [TYCHASIS CORPORATION]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCOATS ALOE (ALLANTOIN) JELLY [TYCHASIS CORPORATION]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECOATS ALOE (ALLANTOIN) JELLY [TYCHASIS CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70211-705COATS ALOE (ALLANTOIN) JELLY [TYCHASIS CORPORATION]4Legacy NDC, 1 package rows20241030_2393ef7e-c7da-07b4-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1442087allantoin 0.5 % Topical GelPSN2393ef7e-c7da-07b4-e054-00144ff88e884
1442087allantoin 0.005 MG/MG Topical GelSCD2393ef7e-c7da-07b4-e054-00144ff88e884
1442087allantoin 0.5 % Topical GelSY2393ef7e-c7da-07b4-e054-00144ff88e884

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70211-705-0870211070508237 mL in 1 BOTTLE, DISPENSING (70211-705-08) 237 ml2015-11-020000-00-00NoNoCurrent