FDA.reportPublic FDA data

Childrens Allergy

Product NDC
66007-212
11-digit product format
660070212
Labeler code
66007
Product ID
66007-212_557a995c-3fe4-411c-94ef-f6d4f1bd0a55
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Capricorn Pharma Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2010-09-29
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
13 mg/1
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct66007-212IInactivated by FDA2026-07-31
excluded packagepackage66007-21266007-212-02IInactivated by FDA2026-07-31

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66007-212-022019-10-29C16284748780-1960f7f55-cd64-8e05-e053-dbdaa90a074aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66007-212-01Childrens Allergy6 in 1 BLISTER PACKTABLET61
66007-212-02Childrens Allergy3 in 1 CARTONTABLET31

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CAPRICORN PHARMA INC.]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MCHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CAPRICORN PHARMA INC.]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XCHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CAPRICORN PHARMA INC.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CAPRICORN PHARMA INC.]1
CAPRYLIC/CAPRIC MONO/DIGLYCERIDESINACTIVE INGREDIENTU72Q2I8C85CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CAPRICORN PHARMA INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CAPRICORN PHARMA INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CAPRICORN PHARMA INC.]1
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPCHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CAPRICORN PHARMA INC.]1
ETHYLCELLULOSEINACTIVE INGREDIENT7Z8S9VYZ4BCHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CAPRICORN PHARMA INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CAPRICORN PHARMA INC.]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DCHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CAPRICORN PHARMA INC.]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ACHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CAPRICORN PHARMA INC.]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JCHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CAPRICORN PHARMA INC.]1
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)INACTIVE INGREDIENT461P5CJN6TCHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CAPRICORN PHARMA INC.]1
OLEIC ACIDINACTIVE INGREDIENT2UMI9U37CPCHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CAPRICORN PHARMA INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CAPRICORN PHARMA INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CAPRICORN PHARMA INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CAPRICORN PHARMA INC.]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CAPRICORN PHARMA INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UCHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CAPRICORN PHARMA INC.]1
TRIACETININACTIVE INGREDIENTXHX3C3X673CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CAPRICORN PHARMA INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66007-212CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CAPRICORN PHARMA INC.]1Legacy NDC, 2 package rows20101012_327ccd2d-dcc6-4919-83d7-51d8920b7b01.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
882504diphenhydrAMINE HCl 12.5 MG Disintegrating Oral TabletPSN327ccd2d-dcc6-4919-83d7-51d8920b7b011
882504diphenhydramine hydrochloride 12.5 MG Disintegrating Oral TabletSCD327ccd2d-dcc6-4919-83d7-51d8920b7b011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66007-212-01660070212016 in 1 BLISTER PACKHistorical
66007-212-02660070212023 in 1 CARTONHistorical