FDA.reportPublic FDA data

Adult Low Dose Aspirin

Product NDC
16103-356
11-digit product format
161030356
Labeler code
16103
Product ID
16103-356_9c7048f1-9ac5-431b-9279-ee6ce88e6d71
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Pharbest Pharmaceuticals, Inc.
Application
M
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2007-01-12
Substance
ASPIRIN
Active strength
81 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
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Adult Low Dose Aspirin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN81 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR16CO5Y76E
Rxcui308416

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
16103-356-092025-01-30C16284748780-19d75b9d0-2e57-f424-e053-dadaa90a57ceDrug Facts
16103-356-112025-01-30C16284748780-19d75b9d0-2e57-f424-e053-dadaa90a57ceDrug Facts
16103-356-092023-06-08C16284748780-19d75b9d0-2e57-f424-e053-dadaa90a57ceDrug Facts
16103-356-112023-06-08C16284748780-19d75b9d0-2e57-f424-e053-dadaa90a57ceDrug Facts
16103-356-092023-01-30C16284748780-19d75b9d0-2e57-f424-e053-dadaa90a57ceDrug Facts
16103-356-112023-01-30C16284748780-19d75b9d0-2e57-f424-e053-dadaa90a57ceDrug Facts
16103-356-092021-03-29C16284748780-19d75b9d0-2e57-f424-e053-dadaa90a57ceDrug Facts
16103-356-112021-03-29C16284748780-19d75b9d0-2e57-f424-e053-dadaa90a57ceDrug Facts
16103-356-092020-01-31C16284748780-19d75b9d0-2e57-f424-e053-dadaa90a57ceDrug Facts
16103-356-112020-01-31C16284748780-19d75b9d0-2e57-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16103-356-09Adult Low Dose Aspirin1 in 1 CARTONTABLET, DELAYED RELEASE14
16103-356-09Adult Low Dose Aspirin120 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE1204
16103-356-11Adult Low Dose Aspirin1000 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16103-356-09EA - Each16103-3562a4fc101-b4b3-4006-94da-4dcc4f99468a12012-07-24
16103-356-11EA - Each16103-3565401e9c5-7206-4514-b71f-0844577ed8af12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EADULT LOW DOSE ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS, INC.]1
ASPIRINACTIVE INGREDIENTR16CO5Y76EADULT LOW DOSE ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [LIBERTY PHARMACEUTICALS, INC.]1
ASPIRINACTIVE INGREDIENTR16CO5Y76EADULT LOW DOSE ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
ASPIRINACTIVE INGREDIENTR16CO5Y76EASPIRIN LOW DOSE (ASPIRIN) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
ASPIRINACTIVE MOIETYR16CO5Y76EADULT LOW DOSE ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [LIBERTY PHARMACEUTICALS, INC.]1
ASPIRINACTIVE MOIETYR16CO5Y76EADULT LOW DOSE ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
ASPIRINACTIVE MOIETYR16CO5Y76EADULT LOW DOSE ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS, INC.]1
ASPIRINACTIVE MOIETYR16CO5Y76EASPIRIN LOW DOSE (ASPIRIN) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UADULT LOW DOSE ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UADULT LOW DOSE ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [LIBERTY PHARMACEUTICALS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UADULT LOW DOSE ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ADULT LOW DOSE ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [LIBERTY PHARMACEUTICALS, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ADULT LOW DOSE ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ADULT LOW DOSE ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GADULT LOW DOSE ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GADULT LOW DOSE ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [LIBERTY PHARMACEUTICALS, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GADULT LOW DOSE ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ADULT LOW DOSE ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ADULT LOW DOSE ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ADULT LOW DOSE ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [LIBERTY PHARMACEUTICALS, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOADULT LOW DOSE ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [LIBERTY PHARMACEUTICALS, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOADULT LOW DOSE ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOADULT LOW DOSE ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JADULT LOW DOSE ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JADULT LOW DOSE ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [LIBERTY PHARMACEUTICALS, INC.]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JADULT LOW DOSE ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AADULT LOW DOSE ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [LIBERTY PHARMACEUTICALS, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AADULT LOW DOSE ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AADULT LOW DOSE ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JADULT LOW DOSE ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JADULT LOW DOSE ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JADULT LOW DOSE ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [LIBERTY PHARMACEUTICALS, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJADULT LOW DOSE ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJADULT LOW DOSE ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJADULT LOW DOSE ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [LIBERTY PHARMACEUTICALS, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APADULT LOW DOSE ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APADULT LOW DOSE ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [LIBERTY PHARMACEUTICALS, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APADULT LOW DOSE ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UADULT LOW DOSE ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UADULT LOW DOSE ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [LIBERTY PHARMACEUTICALS, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UADULT LOW DOSE ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPADULT LOW DOSE ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPADULT LOW DOSE ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPADULT LOW DOSE ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [LIBERTY PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16103-356ADULT LOW DOSE ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 3 package rows20230609_4522f745-b88d-4021-a5dc-0161f1967dc9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSNef9d5cea-86f1-44c2-bca4-70ff5fa1635611
308416aspirin 81 MG Delayed Release Oral TabletSCDef9d5cea-86f1-44c2-bca4-70ff5fa1635611
308416ASA 81 MG Delayed Release Oral TabletSYef9d5cea-86f1-44c2-bca4-70ff5fa1635611
308416aspirin 81 MG Enteric Coated Oral TabletSYef9d5cea-86f1-44c2-bca4-70ff5fa1635611
308416aspirin 81 MG Delayed Release Oral TabletPSN4522f745-b88d-4021-a5dc-0161f1967dc94
308416aspirin 81 MG Delayed Release Oral TabletSCD4522f745-b88d-4021-a5dc-0161f1967dc94
308416ASA 81 MG Delayed Release Oral TabletSY4522f745-b88d-4021-a5dc-0161f1967dc94
308416aspirin 81 MG Enteric Coated Oral TabletSY4522f745-b88d-4021-a5dc-0161f1967dc94
308416aspirin 81 MG Delayed Release Oral TabletPSN1b2e6566-cb7c-7a7d-e063-6394a90af97c2
308416aspirin 81 MG Delayed Release Oral TabletSCD1b2e6566-cb7c-7a7d-e063-6394a90af97c2
308416ASA 81 MG Delayed Release Oral TabletSY1b2e6566-cb7c-7a7d-e063-6394a90af97c2
308416aspirin 81 MG Enteric Coated Oral TabletSY1b2e6566-cb7c-7a7d-e063-6394a90af97c2
308416aspirin 81 MG Delayed Release Oral TabletPSN466f6fa5-79f9-4f53-971d-a5254b0750e31
308416aspirin 81 MG Delayed Release Oral TabletPSN47b595dd-51ff-4400-91d5-c814a5c80eb41
308416aspirin 81 MG Delayed Release Oral TabletPSNb427f43b-6c79-4141-9709-8da63d198cc81
308416aspirin 81 MG Delayed Release Oral TabletSCD466f6fa5-79f9-4f53-971d-a5254b0750e31
308416aspirin 81 MG Delayed Release Oral TabletSCD47b595dd-51ff-4400-91d5-c814a5c80eb41
308416aspirin 81 MG Delayed Release Oral TabletSCDb427f43b-6c79-4141-9709-8da63d198cc81
308416ASA 81 MG Delayed Release Oral TabletSY47b595dd-51ff-4400-91d5-c814a5c80eb41
308416ASA 81 MG Delayed Release Oral TabletSYb427f43b-6c79-4141-9709-8da63d198cc81
308416ASA 81 MG Delayed Release Oral TabletSY466f6fa5-79f9-4f53-971d-a5254b0750e31
308416aspirin 81 MG Enteric Coated Oral TabletSY466f6fa5-79f9-4f53-971d-a5254b0750e31
308416aspirin 81 MG Enteric Coated Oral TabletSY47b595dd-51ff-4400-91d5-c814a5c80eb41
308416aspirin 81 MG Enteric Coated Oral TabletSYb427f43b-6c79-4141-9709-8da63d198cc81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16103-356-09161030356091 BOTTLE, PLASTIC in 1 CARTON (16103-356-09) / 120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2007-01-120000-00-00NoNoCurrent
16103-356-11161030356111000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (16103-356-11) 2007-01-120000-00-00NoNoCurrent