FDA.reportPublic FDA data

COATS ALOE

Product NDC
70211-702
Requested package NDC
70211-702-02
11-digit product format
702110702
Labeler code
70211
Product ID
70211-702_f18f35fc-91a0-c061-e053-2a95a90a2e48
Type
HUMAN OTC DRUG
Nonproprietary name
ALLANTOIN
Dosage form
LOTION
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 packagepackage70211-70270211-702-02IInactivated 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 packagepackage70211-70270211-702-02EExcluded 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.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70211-702-022026-01-29C16284748780-149896155-a478-586f-e063-e6dba90add90COATS ALOE LOTION
70211-702-082026-01-29C16284748780-149896155-a478-586f-e063-e6dba90add90COATS ALOE LOTION
70211-702-332026-01-29C16284748780-149896155-a478-586f-e063-e6dba90add90COATS ALOE LOTION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70211-702-02COATS ALOE59 mL in 1 BOTTLE, DISPENSINGLOTION594
70211-702-08COATS ALOE237 mL in 1 BOTTLE, DISPENSINGLOTION2374
70211-702-33COATS ALOE976 mL in 1 BOTTLE, DISPENSINGLOTION9764

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70211-702-02ML - Milliliter70211-70297513aff-3dbe-4b56-a255-e51ad2ee581212016-02-04
70211-702-08ML - Milliliter70211-702258de705-e53b-42fd-b96b-8fa5cff0c24a12016-02-04
70211-702-33ML - Milliliter70211-7022cfa267e-2bef-40be-b20a-7cceb812f26012016-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALLANTOINACTIVE INGREDIENT344S277G0ZCOATS ALOE (ALLANTOIN) LOTION [TYCHASIS CORPORATION]1
ALLANTOINACTIVE MOIETY344S277G0ZCOATS ALOE (ALLANTOIN) LOTION [TYCHASIS CORPORATION]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XCOATS ALOE (ALLANTOIN) LOTION [TYCHASIS CORPORATION]1
BOROGLYCERININACTIVE INGREDIENTU3LMU4AN21COATS ALOE (ALLANTOIN) LOTION [TYCHASIS CORPORATION]1
C12-15 ALKYL BENZOATEINACTIVE INGREDIENTA9EJ3J61HQCOATS ALOE (ALLANTOIN) LOTION [TYCHASIS CORPORATION]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNCOATS ALOE (ALLANTOIN) LOTION [TYCHASIS CORPORATION]1
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4COATS ALOE (ALLANTOIN) LOTION [TYCHASIS CORPORATION]1
DIETHYLHEXYL ADIPATEINACTIVE INGREDIENTMBY1SL921LCOATS ALOE (ALLANTOIN) LOTION [TYCHASIS CORPORATION]1
ETHYLHEXYL PALMITATEINACTIVE INGREDIENT2865993309COATS ALOE (ALLANTOIN) LOTION [TYCHASIS CORPORATION]1
ETHYLHEXYL STEARATEINACTIVE INGREDIENTEG3PA2K3K5COATS ALOE (ALLANTOIN) LOTION [TYCHASIS CORPORATION]1
GLYCERYL STEARATE SEINACTIVE INGREDIENTFCZ5MH785ICOATS ALOE (ALLANTOIN) LOTION [TYCHASIS CORPORATION]1
LAURETH-23INACTIVE INGREDIENTN72LMW566GCOATS ALOE (ALLANTOIN) LOTION [TYCHASIS CORPORATION]1
LAURETH-4INACTIVE INGREDIENT6HQ855798JCOATS ALOE (ALLANTOIN) LOTION [TYCHASIS CORPORATION]1
METHYL GLUCETH-20INACTIVE INGREDIENTJ3QD0LD11PCOATS ALOE (ALLANTOIN) LOTION [TYCHASIS CORPORATION]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCOATS ALOE (ALLANTOIN) LOTION [TYCHASIS CORPORATION]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCOATS ALOE (ALLANTOIN) LOTION [TYCHASIS CORPORATION]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCOATS ALOE (ALLANTOIN) LOTION [TYCHASIS CORPORATION]1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P8COATS ALOE (ALLANTOIN) LOTION [TYCHASIS CORPORATION]1
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCCOATS ALOE (ALLANTOIN) LOTION [TYCHASIS CORPORATION]1
WATERINACTIVE INGREDIENT059QF0KO0RCOATS ALOE (ALLANTOIN) LOTION [TYCHASIS CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70211-702COATS ALOE (ALLANTOIN) LOTION [TYCHASIS CORPORATION]4Legacy NDC, 3 package rows20241030_23939910-3d59-5ffb-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1087954allantoin 0.5 % Topical LotionPSN23939910-3d59-5ffb-e054-00144ff8d46c4
1087954allantoin 5 MG/ML Topical LotionSCD23939910-3d59-5ffb-e054-00144ff8d46c4
1087954allantoin 0.5 % Topical LotionSY23939910-3d59-5ffb-e054-00144ff8d46c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70211-702-027021107020259 mL in 1 BOTTLE, DISPENSING (70211-702-02) 59 ml2015-11-020000-00-00NoNoCurrent