FDA.reportPublic FDA data

Aspirin

Product NDC
0536-1234
11-digit product format
005361234
Labeler code
0536
Product ID
0536-1234_8740c050-c1b4-4aba-b904-c950e0281a27
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Rugby Laboratories
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-07-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN81 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R16CO5Y76EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308416Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
63fcd93a-b1db-44ba-8f2b-055a7deb205dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
0536-1234-41AspirinLow Dose1 in 1 CARTONTABLET, DELAYED RELEASE111
0536-1234-41AspirinLow Dose120 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE12011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1234-41EA - Each0536-123427f06810-6187-43ff-bc6b-ba3b6bc9287612019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1234ASPIRIN LOW DOSE (ASPIRIN) TABLET, DELAYED RELEASE [RUGBY LABORATORIES]10Current NDC, Legacy NDC, 2 package rows20250412_63fcd93a-b1db-44ba-8f2b-055a7deb205d.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 85 · 1,689 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Pain plus Fever ReliefACETAMINOPHENCVS PHARMACYe4cbfb06-d826-4d08-95d6-60305c4176252026-08-14WarningsExact identifier
application number: M013
Childrens Pain ReliefACETAMINOPHENCVS Pharmacy,Inc.3738d35c-1e83-40df-9292-c54e6b2c83532026-08-14WarningsExact identifier
application number: M013
CVS Childrens Pain plus Fever ReliefACETAMINOPHENCVS PHARMACY22a48a33-995b-481e-9e4e-1ad7ec346f442026-08-14WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENTopco Associates, LLC8b9e90da-98e2-4d8d-bf6e-54b0a8f8d1012026-08-12WarningsExact identifier
application number: M013
Aspirin 81mgASPIRINHARRIS TEETER54e69d5a-55d7-4ebe-8494-0be93613f1e22026-08-12WarningsExact identifier
application number: M013
Chewable AspirinASPIRINHARRIS TEETERc6a28c83-60c9-3304-e053-2a95a90aa06c2026-08-12WarningsExact identifier
application number: M013
ASPIRINASPIRINHARRIS TEETER93cbd3cb-1072-89e6-e053-2995a90a2f152026-08-12WarningsExact identifier
application number: M013
Adult Chewable AspirinASPIRINHARRIS TEETERc6a28617-1769-7a7d-e053-2995a90a1ea02026-08-12WarningsExact identifier
application number: M013
Gencare- Pain Relief AcetaminophenACETAMINOPHENPioneer Life Sciences, LLC2111c91b-2fd7-4ab3-946a-d4e0cf46399a2026-08-12WarningsExact identifier
application number: M013
Pain Reliever Extra StrengthACETAMINOPHENSalado Sales, Inc.1dbd8480-5cb4-4577-9091-b2a2add4f1af2026-08-12WarningsExact identifier
application number: M013
pain relief childrensACETAMINOPHENRite Aid Corporation29ecdd2d-aeaf-40a8-a347-011088009ea62026-08-11WarningsExact identifier
application number: M013
Fast Acting Pedia CraeACETAMINOPHENRandob Labs., Ltd.e069060f-fbb2-4c7a-b872-00b3ab86d01b2026-08-11WarningsExact identifier
application number: M013
ASPIRINASPIRINAmazon.com Services LLCc7cc0681-4c0b-4565-99df-d0168c8ba1ba2026-08-10WarningsExact identifier
application number: M013
GenCare Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEPioneer Life Sciences, LLCac8c4bdf-30c9-2b09-e053-2a95a90a9b672026-08-09WarningsExact identifier
application number: M013
Gencare-Aspirin Low Dose Pain reliever (NSAID)ASPIRINPioneer Life Sciences, LLC24d4f46a-c7a5-4e94-804f-1e307d8e8cfc2026-08-09WarningsExact identifier
application number: M013
Aspirin 81 mgASPIRINDOLGENCORP, LLCb4064039-2345-4227-b83d-54dc13a838d32026-08-07WarningsExact identifier
application number: M013
berkley and jensen acetaminophenACETAMINOPHENBJWCdee57d73-73ac-48bb-b1da-9971f1ff21c42026-08-07WarningsExact identifier
application number: M013
AspirinASPIRINP & L Development, LLC4cd74cec-a209-4e92-b853-fbe5c95f76782026-08-06WarningsExact identifier
application number: M013
Tension Headache Aspirin-FreeACETAMINOPHEN, CAFFEINERite Aid Corporation093a7c26-f2b1-4416-b193-81133d247d2e2026-08-06WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENKroger Companybc17b2e5-4828-6a2e-e053-2995a90a8c632026-08-05WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSN63fcd93a-b1db-44ba-8f2b-055a7deb205d11
308416aspirin 81 MG Delayed Release Oral TabletSCD63fcd93a-b1db-44ba-8f2b-055a7deb205d11
308416ASA 81 MG Delayed Release Oral TabletSY63fcd93a-b1db-44ba-8f2b-055a7deb205d11
308416aspirin 81 MG Enteric Coated Oral TabletSY63fcd93a-b1db-44ba-8f2b-055a7deb205d11
308416aspirin 81 MG Delayed Release Oral TabletPSN8575ef9d-2eae-412a-a252-82b03f4d52755
308416aspirin 81 MG Delayed Release Oral TabletSCD8575ef9d-2eae-412a-a252-82b03f4d52755
308416ASA 81 MG Delayed Release Oral TabletSY8575ef9d-2eae-412a-a252-82b03f4d52755
308416aspirin 81 MG Enteric Coated Oral TabletSY8575ef9d-2eae-412a-a252-82b03f4d52755
308416aspirin 81 MG Delayed Release Oral TabletPSN024c5054-959f-4ea5-a71f-c0e16cc4b90c3
308416aspirin 81 MG Delayed Release Oral TabletPSN3294ba24-f198-485e-88fc-435964434b803
308416aspirin 81 MG Delayed Release Oral TabletSCD024c5054-959f-4ea5-a71f-c0e16cc4b90c3
308416aspirin 81 MG Delayed Release Oral TabletSCD3294ba24-f198-485e-88fc-435964434b803
308416ASA 81 MG Delayed Release Oral TabletSY024c5054-959f-4ea5-a71f-c0e16cc4b90c3
308416ASA 81 MG Delayed Release Oral TabletSY3294ba24-f198-485e-88fc-435964434b803
308416aspirin 81 MG Enteric Coated Oral TabletSY024c5054-959f-4ea5-a71f-c0e16cc4b90c3
308416aspirin 81 MG Enteric Coated Oral TabletSY3294ba24-f198-485e-88fc-435964434b803
308416aspirin 81 MG Delayed Release Oral TabletPSN29214eec-860c-43f0-83c6-9ed5a9f530af1
308416aspirin 81 MG Delayed Release Oral TabletPSNedb256e9-87ce-1fa5-e053-2995a90ac0651
308416aspirin 81 MG Delayed Release Oral TabletSCD29214eec-860c-43f0-83c6-9ed5a9f530af1
308416aspirin 81 MG Delayed Release Oral TabletSCDedb256e9-87ce-1fa5-e053-2995a90ac0651
308416ASA 81 MG Delayed Release Oral TabletSY29214eec-860c-43f0-83c6-9ed5a9f530af1
308416ASA 81 MG Delayed Release Oral TabletSYedb256e9-87ce-1fa5-e053-2995a90ac0651
308416aspirin 81 MG Enteric Coated Oral TabletSY29214eec-860c-43f0-83c6-9ed5a9f530af1
308416aspirin 81 MG Enteric Coated Oral TabletSYedb256e9-87ce-1fa5-e053-2995a90ac0651

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0536-1234-41005361234411 BOTTLE, PLASTIC in 1 CARTON (0536-1234-41) / 120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2019-07-010000-00-00NoNoCurrent