Adult Low Dose Aspirin Enteric Coated

Product NDC
16103-351
11-digit product format
161030351
Labeler code
16103
Product ID
16103-351_45b929af-8d23-4414-9c47-fe92e6c7e9af
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin 81mg
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Pharbest Pharmaceuticals, Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-02-20
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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage16103-351-11ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage16103-351-09ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage16103-351-16ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage16103-351-11367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage16103-351-09367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage16103-351-16367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage16103-351-11557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage16103-351-09557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage16103-351-16557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage16103-351-118af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage16103-351-098af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage16103-351-168af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage16103-351-11834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage16103-351-09834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage16103-351-16834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage16103-351-111332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage16103-351-091332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage16103-351-161332a3947898…d4bfe170f9cd…

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
Adult Low Dose Aspirin Enteric Coated
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
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
45e5bae9-22a7-4699-85ea-5b922af6b96dAvailable on FDA.report

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
16103-351-092024-12-31Drug Facts
16103-351-112024-12-31Drug Facts
16103-351-162024-12-31Drug Facts
16103-351-092023-01-30Drug Facts
16103-351-112023-01-30Drug Facts
16103-351-162023-01-30Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16103-351-09Adult Low Dose Aspirin Enteric Coated120 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE1204
16103-351-11Adult Low Dose Aspirin Enteric Coated1000 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE10004
16103-351-16Adult Low Dose Aspirin Enteric Coated300 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE3004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16103-351ADULT LOW DOSE ASPIRIN ENTERIC COATED (ASPIRIN 81MG) TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 3 package rows20250101_45e5bae9-22a7-4699-85ea-5b922af6b96d.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 5 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SurviveX Travel Med MODCONVENIENCE KITIntent Brands LLC522da86b-cfd7-dd20-e063-6394a90a51c62026-08-04WarningsExact identifier
application number: M013
Extra Strength Pain Reliever mini softgelsACETAMINOPHEN 500 MGShield Pharmaceuticals Corp0ebb1902-6f8a-4bfb-9f2e-839d43bfca372026-08-04WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENBetter Living Brands, LLC743af02c-c762-42f5-8e01-2f62da15e04e2026-08-04WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENAurohealth LLC9aea8aae-8702-4c93-8b07-69cd252f44d62026-08-03WarningsExact identifier
application number: M013
Pain Relief Acetaminophen 325 mgACETAMINOPHENNUVICARE LLC49a59b79-b8b4-4bf5-a403-0a14751efc552026-08-03WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENAurohealth LLCd4e98f8e-f24c-4bdd-b750-fa4f877fb6212026-07-31WarningsExact identifier
application number: M013
KinderFarms Childrens Pain and FeverACETAMINOPHENKinderFarms, LLC4f86419a-b940-a9c6-e063-6394a90a6a2b2026-07-30WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENFamily Dollar Stores, LLC53f7a9c8-f40e-19b2-e063-6394a90a86952026-07-29WarningsExact identifier
application number: M013
KinderFarms Infants Pain and FeverACETAMINOPHENKinderFarms, LLC5468b149-8fac-8d6a-e063-6294a90a8c512026-07-29WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCVS PHARMACY258975d2-d8e8-407d-9804-df3b37a184e42026-07-29WarningsExact identifier
application number: M013
AspirinASPIRINDolgencorp, Inc. (DOLLAR GENERAL & REXALL)3ba0a9f2-062a-401e-82eb-54383a8223662026-07-29WarningsExact identifier
application number: M013
Aspirin 81mg Enteric CoatedASPIRINCardinal Health 107, LLC277723db-3578-4842-92eb-2de325f876492026-07-28WarningsExact identifier
application number: M013
Aspirin Low Dose ChewableASPIRINBetter Living Brands, LLC7afce7b4-c86a-43f7-83cf-15ebffba2f352026-07-28WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENAurohealth LLCf818996c-36d2-4d3d-af3e-39949157edb92026-07-28WarningsExact identifier
application number: M013
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLL.N.K. International, Inc.03b871e8-3e14-4ed8-a978-45129255b2722026-07-27WarningsExact identifier
application number: M013
Pain Relief Acetaminophen PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HCLRite Aid Corporation17d27771-a112-474f-9a58-29af0d7e1af32026-07-27WarningsExact identifier
application number: M013
Infants TYLENOLACETAMINOPHENKenvue Brands LLC2143cc16-86db-4060-96da-5c228ae9207b2026-07-24WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENSoftgel Healthcare Pvt Ltd352bb451-ffdc-411a-e063-6294a90a8cf52026-07-24WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENNuCare Pharmaceuticals,Inc.fdb7331a-d029-8b2a-e053-6294a90adfcd2026-07-24WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENAurohealth LLC5ada044e-50e8-4874-ac04-df5f1f9e735d2026-07-24WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSN45e5bae9-22a7-4699-85ea-5b922af6b96d4
308416aspirin 81 MG Delayed Release Oral TabletSCD45e5bae9-22a7-4699-85ea-5b922af6b96d4
308416ASA 81 MG Delayed Release Oral TabletSY45e5bae9-22a7-4699-85ea-5b922af6b96d4
308416aspirin 81 MG Enteric Coated Oral TabletSY45e5bae9-22a7-4699-85ea-5b922af6b96d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16103-351-0916103035109120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (16103-351-09) 2019-02-200000-00-00NoNoCurrent
16103-351-11161030351111000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (16103-351-11) 2019-02-200000-00-00NoNoCurrent
16103-351-1616103035116300 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (16103-351-16) 2019-02-200000-00-00NoNoCurrent