FDA.reportPublic FDA data

COATS ALOE

Product NDC
70211-703
11-digit product format
702110703
Labeler code
70211
Product ID
70211-703_f18f1137-4bda-6155-e053-2995a90a688f
Type
HUMAN OTC DRUG
Nonproprietary name
ALLANTOIN
Dosage form
CREAM
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 mg/100g
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70211-703IInactivated by FDA2026-10-05
excluded packagepackage70211-70370211-703-04IInactivated by FDA2026-10-05
excluded packagepackage70211-70370211-703-16IInactivated 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 · 3 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 productproduct70211-703EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage70211-70370211-703-16EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage70211-70370211-703-04EExcluded 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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70211-703-04COATS ALOE118 g in 1 JARCREAM1184
70211-703-16COATS ALOE454 g in 1 JARCREAM4544

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70211-703-04GM - Gram70211-703355061e9-ea6d-408a-ae87-44eac396ec5512016-02-04
70211-703-16GM - Gram70211-703c04f44b7-06f7-485c-aa3a-d1753e860dbd12016-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALLANTOINACTIVE INGREDIENT344S277G0ZCOATS ALOE (ALLANTOIN) CREAM [TYCHASIS CORPORATION]1
ALLANTOINACTIVE MOIETY344S277G0ZCOATS ALOE (ALLANTOIN) CREAM [TYCHASIS CORPORATION]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XCOATS ALOE (ALLANTOIN) CREAM [TYCHASIS CORPORATION]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHCOATS ALOE (ALLANTOIN) CREAM [TYCHASIS CORPORATION]1
C12-15 ALKYL BENZOATEINACTIVE INGREDIENTA9EJ3J61HQCOATS ALOE (ALLANTOIN) CREAM [TYCHASIS CORPORATION]1
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDEINACTIVE INGREDIENTFJ1H6M2JG9COATS ALOE (ALLANTOIN) CREAM [TYCHASIS CORPORATION]1
DEHYDROACETIC ACIDINACTIVE INGREDIENT2KAG279R6RCOATS ALOE (ALLANTOIN) CREAM [TYCHASIS CORPORATION]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCOATS ALOE (ALLANTOIN) CREAM [TYCHASIS CORPORATION]1
GLYCERYL STEARATE SEINACTIVE INGREDIENTFCZ5MH785ICOATS ALOE (ALLANTOIN) CREAM [TYCHASIS CORPORATION]1
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4THCOATS ALOE (ALLANTOIN) CREAM [TYCHASIS CORPORATION]1
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW)INACTIVE INGREDIENTJ2S07SB0YLCOATS ALOE (ALLANTOIN) CREAM [TYCHASIS CORPORATION]1
PENTYLENE GLYCOLINACTIVE INGREDIENT50C1307PZGCOATS ALOE (ALLANTOIN) CREAM [TYCHASIS CORPORATION]1
POTASSIUM PALMITATEINACTIVE INGREDIENTKTC40CLC68COATS ALOE (ALLANTOIN) CREAM [TYCHASIS CORPORATION]1
SHEA BUTTERINACTIVE INGREDIENTK49155WL9YCOATS ALOE (ALLANTOIN) CREAM [TYCHASIS CORPORATION]1
WATERINACTIVE INGREDIENT059QF0KO0RCOATS ALOE (ALLANTOIN) CREAM [TYCHASIS CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70211-703COATS ALOE (ALLANTOIN) CREAM [TYCHASIS CORPORATION]4Legacy NDC, 2 package rows20241030_2390d20f-58c4-084e-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
241509allantoin 0.5 % Topical CreamPSN2390d20f-58c4-084e-e054-00144ff88e884
241509allantoin 5 MG/ML Topical CreamSCD2390d20f-58c4-084e-e054-00144ff88e884
241509allantoin 0.5 % Topical CreamSY2390d20f-58c4-084e-e054-00144ff88e884

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70211-703-0470211070304118 g in 1 JAR (70211-703-04) 118 g2015-11-020000-00-00NoNoCurrent
70211-703-1670211070316454 g in 1 JAR (70211-703-16) 454 g2015-11-020000-00-00NoNoCurrent