FDA.reportPublic FDA data

Enteric Aspirin

Product NDC
63868-898
11-digit product format
638680898
Labeler code
63868
Product ID
63868-898_ac2d47b0-2641-4474-a8d3-bc1d362edbad
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
CHAIN DRUG MARKETING ASSOCIATION INC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1992-12-14
Marketing end
2026-09-30
Substance
ASPIRIN
Active strength
325 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Enteric Aspirin

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN325 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR16CO5Y76E
Rxcui198467

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-898-10Enteric Aspirin1 in 1 CARTONTABLET, DELAYED RELEASE115
63868-898-10Enteric Aspirin100 in 1 BOTTLETABLET, DELAYED RELEASE10015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-898-10EA - Each63868-898ac38353f-1077-45d3-9d12-1f2b9061c57612017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EENTERIC ASPIRIN (ASPIRIN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION INC]3
ASPIRINACTIVE MOIETYR16CO5Y76EENTERIC ASPIRIN (ASPIRIN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION INC]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ENTERIC ASPIRIN (ASPIRIN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION INC]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOENTERIC ASPIRIN (ASPIRIN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION INC]3
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEENTERIC ASPIRIN (ASPIRIN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION INC]3
Polyvinyl Acetate PhthalateINACTIVE INGREDIENT58QVG85GW3ENTERIC ASPIRIN (ASPIRIN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION INC]3
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MENTERIC ASPIRIN (ASPIRIN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION INC]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ENTERIC ASPIRIN (ASPIRIN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION INC]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ENTERIC ASPIRIN (ASPIRIN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION INC]3
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQENTERIC ASPIRIN (ASPIRIN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION INC]3
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOENTERIC ASPIRIN (ASPIRIN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION INC]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJENTERIC ASPIRIN (ASPIRIN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION INC]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APENTERIC ASPIRIN (ASPIRIN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION INC]3
TALCINACTIVE INGREDIENT7SEV7J4R1UENTERIC ASPIRIN (ASPIRIN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION INC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPENTERIC ASPIRIN (ASPIRIN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION INC]3
TRIACETININACTIVE INGREDIENTXHX3C3X673ENTERIC ASPIRIN (ASPIRIN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION INC]3
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMENTERIC ASPIRIN (ASPIRIN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-898ENTERIC ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION INC]14Current NDC, Legacy NDC, 2 package rows20241025_a791d664-99fe-4cba-95cf-f49baedde326.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198467aspirin 325 MG Delayed Release Oral TabletPSNa791d664-99fe-4cba-95cf-f49baedde32615
198467aspirin 325 MG Delayed Release Oral TabletSCDa791d664-99fe-4cba-95cf-f49baedde32615
198467ASA 325 MG Delayed Release Oral TabletSYa791d664-99fe-4cba-95cf-f49baedde32615
198467aspirin 325 MG Enteric Coated Oral TabletSYa791d664-99fe-4cba-95cf-f49baedde32615

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-898-10638680898101 BOTTLE in 1 CARTON (63868-898-10) / 100 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle1992-12-142026-09-30NoNoCurrent