FDA.reportPublic FDA data

Aspirin Low Dose Chewable Orange

Product NDC
0904-6794
11-digit product format
009046794
Labeler code
0904
Product ID
0904-6794_f2922418-7d2c-4a41-b28a-41769521b297
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
MAJOR PHARMACEUTICALS
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-09-27
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

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 packagepackage0904-67940904-6794-30DDiscontinued by firm2026-10-21

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Aspirin Low Dose Chewable Orange
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
318272Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fb3a8e38-e991-49c9-93dc-1d29c0a97ba3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
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
0904-6794-30Aspirin Low Dose Chewable Orange300 in 1 CARTONTABLET, CHEWABLE3007
0904-6794-30Aspirin Low Dose Chewable Orange1 in 1 BLISTER PACKTABLET, CHEWABLE17
0904-6794-80Aspirin Low Dose Chewable Orange1000 in 1 PACKAGETABLET, CHEWABLE10007
0904-6794-89Aspirin Low Dose Chewable Orange90 in 1 BOTTLE, PLASTICTABLET, CHEWABLE907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6794-30EA - Each0904-67940b6b3501-8a59-4d48-864f-25efe4b4475912023-04-07
0904-6794-80EA - Each0904-679478376407-1c58-42be-9458-6e0c6219806812018-11-06
0904-6794-89EA - Each0904-6794b50d3dc8-f0d6-49f7-ac05-baa38562ec1d12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6794ASPIRIN LOW DOSE CHEWABLE ORANGE (ASPIRIN) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]5Current NDC, Legacy NDC, 4 package rows20241226_fb3a8e38-e991-49c9-93dc-1d29c0a97ba3.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 75 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alka-SeltzerBUFFERED ASPIRINLil' Drug Store Products, Inc.0c7a60e7-0bde-9aa2-e063-6294a90a32092023-12-14WarningsExact identifier
application number: M013
Circle K Aspirin 325ASPIRINLil Drug Store Products, Inc4cd306e3-2119-4272-9da4-a848fe2746fa2023-12-14WarningsExact identifier
application number: M013
Circle K Pain Reliever Extra StrengthACETAMINOPHENLil' Drug Store Products, Inc.f2359bc3-901f-4ecb-b402-cb2fe404a9352023-12-14WarningsExact identifier
application number: M013
Childrens Pain ReliefACETAMINOPHENDISCOUNT DRUG MARTc55b8f9d-1396-43c0-acc9-5e3485eadb072023-12-08WarningsExact identifier
application number: M013
Childrens Pain ReliefACETAMINOPHENDISCOUNT DRUG MART775519ad-5683-451f-9bfc-5fafc70c68ec2023-12-08WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENWALGREEN CO.c20c814b-35f5-4c46-e053-2a95a90a50f22023-12-08WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENBetter Living Brands LLCf9859be4-6d0b-2ab8-e053-6294a90aa8622023-12-06WarningsExact identifier
application number: M013
Aurophen Regular StrengthACETAMINOPHENKROGER COMPANYb9b7b849-c3b3-9af7-e053-2a95a90a00772023-12-06WarningsExact identifier
application number: M013
Acetaminophen Regular StrengthACETAMINOPHENKROGER COMPANYcf649478-57d2-cc88-e053-2a95a90ad1ba2023-12-06WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENKROGER COMPANYb9b6f878-1ec8-3dc0-e053-2995a90a54142023-12-06WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWALGREEN CO.a48c522c-76c5-49f8-8c4d-3ee6b221e6f32023-12-06WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWALGREEN CO.cc939a7c-ce56-5dd6-e053-2995a90aa8af2023-12-06WarningsExact identifier
application number: M013
Alka-Seltzer Original FlavorBUFFERED ASPIRIN, EFFERVESCENT TABLETLil' Drug Store Products, Inc.ea5df8be-a08c-5fa3-e053-2995a90a0bac2023-12-06WarningsExact identifier
application number: M013
RinglACETAMINOPHENSato Pharmaceutical Co., Ltd.ba5a0286-3e0f-4bef-96e5-29d92f51f4322023-12-06WarningsExact identifier
application number: M013
Pain Relief ChildrensACETAMINOPHENDolgencorp, Inc. (DOLLAR GENERAL & REXALL)41633554-474e-4d3c-9187-d90487d2ae8c2023-12-06WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENFamily Dollar Stores, LLCf86dcbb8-debc-4bce-e053-6294a90a7a022023-12-05WarningsExact identifier
application number: M013
Sanatos Multi Symptom DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBRPharmadel LLC0a5fc0ef-ba34-bb0b-e063-6394a90af7d92023-12-01WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENProficient Rx LP402c8563-b14b-453f-80bc-4275f1c737022023-12-01WarningsExact identifier
application number: M013
Acetaminophen and Diphenhydramine hydrochlorideACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEAurohealth LLC3ba51b52-7ae6-4335-b178-1b7b6ef362272023-11-29WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENAurohealth LLCbc03fa56-8880-4bbd-81a0-91853fecdd4e2023-11-29WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
318272aspirin 81 MG Chewable TabletPSNdbdc7cae-b2ed-4504-83a0-0a41b4e4500310
318272aspirin 81 MG Chewable TabletSCDdbdc7cae-b2ed-4504-83a0-0a41b4e4500310
318272ASA 81 MG Chewable TabletSYdbdc7cae-b2ed-4504-83a0-0a41b4e4500310
318272aspirin 81 MG Chewable TabletPSNfb3a8e38-e991-49c9-93dc-1d29c0a97ba37
318272aspirin 81 MG Chewable TabletSCDfb3a8e38-e991-49c9-93dc-1d29c0a97ba37
318272ASA 81 MG Chewable TabletSYfb3a8e38-e991-49c9-93dc-1d29c0a97ba37
318272aspirin 81 MG Chewable TabletPSNa0d8ee59-1ce0-4ddd-a90c-54adb512540c4
318272aspirin 81 MG Chewable TabletSCDa0d8ee59-1ce0-4ddd-a90c-54adb512540c4
318272ASA 81 MG Chewable TabletSYa0d8ee59-1ce0-4ddd-a90c-54adb512540c4
318272aspirin 81 MG Chewable TabletPSN4ba6eed3-004a-4576-b7f7-685fae49cf6a3
318272aspirin 81 MG Chewable TabletPSN21042405-9c7e-4a72-8984-27ad3433eaa93
318272aspirin 81 MG Chewable TabletSCD4ba6eed3-004a-4576-b7f7-685fae49cf6a3
318272aspirin 81 MG Chewable TabletSCD21042405-9c7e-4a72-8984-27ad3433eaa93
318272ASA 81 MG Chewable TabletSY21042405-9c7e-4a72-8984-27ad3433eaa93
318272ASA 81 MG Chewable TabletSY4ba6eed3-004a-4576-b7f7-685fae49cf6a3
318272aspirin 81 MG Chewable TabletPSN13e621dc-b2b4-98fd-e063-6394a90acc751
318272aspirin 81 MG Chewable TabletPSN9e08b91c-b067-4ccd-ae0d-01f48f992f201
318272aspirin 81 MG Chewable TabletSCD9e08b91c-b067-4ccd-ae0d-01f48f992f201
318272aspirin 81 MG Chewable TabletSCD13e621dc-b2b4-98fd-e063-6394a90acc751
318272ASA 81 MG Chewable TabletSY9e08b91c-b067-4ccd-ae0d-01f48f992f201
318272ASA 81 MG Chewable TabletSY13e621dc-b2b4-98fd-e063-6394a90acc751

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0904-6794-3000904679430300 in 1 CARTONHistorical
0904-6794-80009046794801000 TABLET, CHEWABLE in 1 PACKAGE (0904-6794-80) 2018-09-270000-00-00NoNoCurrent
0904-6794-890090467948990 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (0904-6794-89) 2018-09-270000-00-00NoNoCurrent