FDA.reportPublic FDA data

Low Dose Aspirin

Product NDC
16103-366
11-digit product format
161030366
Labeler code
16103
Product ID
16103-366_9031ec5c-852d-4434-8099-e0fc6fa7b92d
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Pharbest Pharmaceuticals, Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2007-08-22
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage16103-366-11e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage16103-366-05e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage16103-366-119bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage16103-366-059bebd1f3094a…5416666fcb17…

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
Low Dose Aspirin
Listing expiration
2026-12-31

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
2763a733-d617-4d95-8429-fbf81d9d77fbAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
16103-366-052023-06-08Drug Facts
16103-366-112023-06-08Drug Facts
16103-366-052023-01-30Drug Facts
16103-366-112023-01-30Drug Facts
16103-366-052021-03-30Drug Facts
16103-366-112021-03-30Drug Facts
16103-366-052020-01-31Drug Facts
16103-366-112020-01-31Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16103-366-05Low Dose Aspirin36 in 1 BOTTLE, PLASTICTABLET, CHEWABLE365
16103-366-05Low Dose Aspirin1 in 1 CARTONTABLET, CHEWABLE15
16103-366-11Low Dose Aspirin1000 in 1 BOTTLE, PLASTICTABLET, CHEWABLE10005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16103-366-05EA - Each16103-36643e318c1-7d8b-4f10-84ab-569525198cf912013-05-02
16103-366-11EA - Each16103-3662d57c73f-13ee-45d4-ba9d-0539d67d4a8612013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76ELOW DOSE ASPIRIN (ASPIRIN) TABLET, CHEWABLE [PHARBEST PHARMACEUTICALS, INC.]1
ASPIRINACTIVE INGREDIENTR16CO5Y76EASPIRIN LOW DOSE CHEWABLE (ASPIRIN) TABLET, CHEWABLE [CONTRACT PHARMACY SERVICES-PA]1
ASPIRINACTIVE MOIETYR16CO5Y76ELOW DOSE ASPIRIN (ASPIRIN) TABLET, CHEWABLE [PHARBEST PHARMACEUTICALS, INC.]1
ASPIRINACTIVE MOIETYR16CO5Y76EASPIRIN LOW DOSE CHEWABLE (ASPIRIN) TABLET, CHEWABLE [CONTRACT PHARMACY SERVICES-PA]1
DEXTROSE MONOHYDRATEINACTIVE INGREDIENTLX22YL083GLOW DOSE ASPIRIN (ASPIRIN) TABLET, CHEWABLE [PHARBEST PHARMACEUTICALS, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LOW DOSE ASPIRIN (ASPIRIN) TABLET, CHEWABLE [PHARBEST PHARMACEUTICALS, INC.]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYLOW DOSE ASPIRIN (ASPIRIN) TABLET, CHEWABLE [PHARBEST PHARMACEUTICALS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LOW DOSE ASPIRIN (ASPIRIN) TABLET, CHEWABLE [PHARBEST PHARMACEUTICALS, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLOW DOSE ASPIRIN (ASPIRIN) TABLET, CHEWABLE [PHARBEST PHARMACEUTICALS, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APLOW DOSE ASPIRIN (ASPIRIN) TABLET, CHEWABLE [PHARBEST PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16103-366LOW DOSE ASPIRIN (ASPIRIN) TABLET, CHEWABLE [PHARBEST PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 3 package rows20250101_2763a733-d617-4d95-8429-fbf81d9d77fb.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 67 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain Relief Extra StrengthACETAMINOPHENChain Drug Marketing Associationcfaf9495-e654-4dfc-ba23-d2358c3720c42024-06-13WarningsExact identifier
application number: M013
Aspirin 81 mg Low DoseASPIRINCHAIN DRUG MARKETING ASSOCIATION, INC.18ff2df8-ee65-4219-ad93-cf5090bfac2d2024-06-13WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION, INC.9fdbaf5e-f88b-4d18-97df-0b2e8dddf3772024-06-13WarningsExact identifier
application number: M013
Aspirin 81 mg Low doseASPIRINCHAIN DRUG MARKETING ASSOCIATION, INC.bfb9af64-3195-44bf-bcf3-6b36b40d3cc72024-06-13WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION, INC.1ac7ed71-5afe-d09c-e063-6294a90a3b882024-06-13WarningsExact identifier
application number: M013
Pain Relief PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.3ce5bbf2-d449-464e-abeb-5c26866d1ab52024-06-13WarningsExact identifier
application number: M013
AspirinASPIRINAAA Pharmaceutical, Inc.609948d6-0f20-4d0c-adc0-6ae72a4f2b7a2024-06-13WarningsExact identifier
application number: M013
AspirinASPIRINAAA Pharmaceutical, Inc.3f73a359-59d7-47bb-872e-914b0db719af2024-06-13WarningsExact identifier
application number: M013
topcare infants pain and feverACETAMINOPHENTopco Associates LLCf1e940ef-3cf0-4a5c-8158-156d0e5a680d2024-06-13WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENTrifecta Pharmaceuticals USA LLC026bf664-d598-73de-e063-6394a90a92062024-06-12WarningsExact identifier
application number: M013
Regular Strength Pain ReliefACETAMINOPHENNuCare Pharmaceuticals,Inc.7c73fc75-af9b-177c-e053-2a91aa0ada562024-06-12WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINTopco Associates4a6a1dbb-c813-42fd-9bb8-497aec3394662024-06-11WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEThe Kroger Co.fa234639-caf8-4c52-9ffe-f1c0c057ee5b2024-06-10WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEThe Kroger Co.bc18590d-6481-4efe-8a3b-974f7543b7542024-06-10WarningsExact identifier
application number: M013
ASPIRINASPIRINH-E-B085b35db-62e4-38db-e063-6394a90a97632024-06-07WarningsExact identifier
application number: M013
pain and feverACETAMINOPHENMeijer Distribution Inccbfa2a25-f1e7-491e-9b67-ff2f4ba0b6cf2024-06-07WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEThe Kroger Co.5691ac45-5732-412e-abb8-2bfaac59160e2024-06-07WarningsExact identifier
application number: M013
Cafiaspirina Rapid Headache ReliefASPIRIN, CAFFEINEBelmora LLCd890acec-6528-4fb7-8d59-6c572a3f07862024-06-07WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINETARGET Corporation611bc1ce-460a-44a3-8e2d-b28a399d9a442024-06-06WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENMeijer Distribution Inc033a6153-2651-4703-8a94-def4618381132024-06-05WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
318272aspirin 81 MG Chewable TabletPSN859e0fbc-052e-42dd-aa4e-746637ff11f511
318272aspirin 81 MG Chewable TabletSCD859e0fbc-052e-42dd-aa4e-746637ff11f511
318272ASA 81 MG Chewable TabletSY859e0fbc-052e-42dd-aa4e-746637ff11f511
318272aspirin 81 MG Chewable TabletPSN1a3ff0da-85eb-542c-e063-6294a90a9cca5
318272aspirin 81 MG Chewable TabletPSN2763a733-d617-4d95-8429-fbf81d9d77fb5
318272aspirin 81 MG Chewable TabletSCD1a3ff0da-85eb-542c-e063-6294a90a9cca5
318272aspirin 81 MG Chewable TabletSCD2763a733-d617-4d95-8429-fbf81d9d77fb5
318272ASA 81 MG Chewable TabletSY1a3ff0da-85eb-542c-e063-6294a90a9cca5
318272ASA 81 MG Chewable TabletSY2763a733-d617-4d95-8429-fbf81d9d77fb5
318272aspirin 81 MG Chewable TabletPSN390334bc-5c58-4c43-8d1c-6a9dc017891b1
318272aspirin 81 MG Chewable TabletSCD390334bc-5c58-4c43-8d1c-6a9dc017891b1
318272ASA 81 MG Chewable TabletSY390334bc-5c58-4c43-8d1c-6a9dc017891b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16103-366-05161030366051 BOTTLE, PLASTIC in 1 CARTON (16103-366-05) / 36 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC2007-08-220000-00-00NoNoCurrent
16103-366-11161030366111000 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (16103-366-11) 2007-08-220000-00-00NoNoCurrent