Home NDC 16103-366 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 date Dataset Scope Package NDC Snapshot Source SHA-256 2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 16103-366-11 e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 16103-366-05 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 16103-366-11 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 16103-366-05 9bebd1f3094a…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 Ingredient Strength ASPIRIN 81 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination R16CO5Y76E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 318272 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 16103-366-05 Low Dose Aspirin 36 in 1 BOTTLE, PLASTIC TABLET, CHEWABLE 36 5 16103-366-05 Low Dose Aspirin 1 in 1 CARTON TABLET, CHEWABLE 1 5 16103-366-11 Low Dose Aspirin 1000 in 1 BOTTLE, PLASTIC TABLET, CHEWABLE 1000 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ASPIRIN ACTIVE INGREDIENT R16CO5Y76E LOW DOSE ASPIRIN (ASPIRIN) TABLET, CHEWABLE [PHARBEST PHARMACEUTICALS, INC.] 1 ASPIRIN ACTIVE INGREDIENT R16CO5Y76E ASPIRIN LOW DOSE CHEWABLE (ASPIRIN) TABLET, CHEWABLE [CONTRACT PHARMACY SERVICES-PA] 1 ASPIRIN ACTIVE MOIETY R16CO5Y76E LOW DOSE ASPIRIN (ASPIRIN) TABLET, CHEWABLE [PHARBEST PHARMACEUTICALS, INC.] 1 ASPIRIN ACTIVE MOIETY R16CO5Y76E ASPIRIN LOW DOSE CHEWABLE (ASPIRIN) TABLET, CHEWABLE [CONTRACT PHARMACY SERVICES-PA] 1 DEXTROSE MONOHYDRATE INACTIVE INGREDIENT LX22YL083G LOW DOSE ASPIRIN (ASPIRIN) TABLET, CHEWABLE [PHARBEST PHARMACEUTICALS, INC.] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 LOW DOSE ASPIRIN (ASPIRIN) TABLET, CHEWABLE [PHARBEST PHARMACEUTICALS, INC.] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY LOW DOSE ASPIRIN (ASPIRIN) TABLET, CHEWABLE [PHARBEST PHARMACEUTICALS, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LOW DOSE ASPIRIN (ASPIRIN) TABLET, CHEWABLE [PHARBEST PHARMACEUTICALS, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ LOW DOSE ASPIRIN (ASPIRIN) TABLET, CHEWABLE [PHARBEST PHARMACEUTICALS, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP LOW DOSE ASPIRIN (ASPIRIN) TABLET, CHEWABLE [PHARBEST PHARMACEUTICALS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16103-366 LOW DOSE ASPIRIN (ASPIRIN) TABLET, CHEWABLE [PHARBEST PHARMACEUTICALS, INC.] 4 Current NDC, Legacy NDC, 3 package rows 20250101_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 22 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TYLENOL Regular Strength ACETAMINOPHEN Kenvue Brands LLC 01f41fae-4abb-4b96-ab09-a7d3dfc286cd 2026-01-26 Warnings Exact identifier application number: M013 pain relief ACETAMINOPHEN Meijer Distribution Inc ec4dbb71-b507-42a3-9b68-14d4b6621ec1 2026-01-23 Warnings Exact identifier application number: M013 Adult Low Dose Aspirin ASPIRIN NCS HealthCare of KY, LLC dba Vangard Labs 9105eff0-1c22-4298-8ee5-9fb7a1de12f1 2026-01-23 Warnings Exact identifier application number: M013 Extra Strength Pain Relief ACETAMINOPHEN Preferred Pharmaceuticals Inc. c70e3b8e-071d-4b9a-9393-ad8aa09c6b6e 2026-01-22 Warnings Exact identifier application number: M013 Tylenol Extra Strength ACETAMINOPHEN Kenvue Brands LLC 17cfa99d-abb2-4d77-9e0e-e77109fbb61a 2026-01-21 Warnings Exact identifier application number: M013 Dr Simi Extra Strength Acetaminophen 250 mg, Aspirin 250 mg, and Caffeine 65 mg ACETAMINOPHEN 250 MG, ASPIRIN 250 MG, AND CAFFEINE 65 MG Farmacias De Similares TX LLC 48ea0a2c-511b-4805-e063-6394a90a1225 2026-01-21 Warnings Exact identifier application number: M013 childrens mapap ACETAMINOPHEN Major Pharmaceuticals a1b0ccf0-cf24-4b34-b42a-aa1cc1e57f60 2026-01-20 Warnings Exact identifier application number: M013 EXTRA STRENGTH ACETAMINOPHEN ACETAMINOPHEN WALGREENS CO. 9b756e4e-6c56-43aa-a5bc-5b649440e759 2026-01-20 Warnings Exact identifier application number: M013 EXTRA STRENGTH PAIN RELIEVER PM ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE WALGREENS CO. 5a58d620-a0ec-48d7-92dd-3f3f78ec10ea 2026-01-20 Warnings Exact identifier application number: M013 equate pain reliever ACETAMINOPHEN Wal-Mart Stores Inc d4e438c6-80dd-4531-91e6-bc4ca7a8570f 2026-01-20 Warnings Exact identifier application number: M013 Unishield Extra Strength Non-Aspirin ACETAMINOPHEN Unishield ba0ec1eb-db85-6a7f-e053-2995a90aafe5 2026-01-19 Warnings Exact identifier application number: M013 pain relief ACETAMINOPHEN HyVee Inc 24acd62f-72b1-418a-b733-7e4888f3c0a3 2026-01-16 Warnings Exact identifier application number: M013 Acetaminophen Extra Strength ACETAMINOPHEN Cardinal Health 110, LLC. DBA Leader dd8b13a5-07df-4cec-92c3-1a662b1e1a56 2026-01-16 Warnings Exact identifier application number: M013 EXTRA STRENGTH HEADACHE RELIEF ACETAMINOPHEN, ASPIRIN, CAFFEINE WALGREENS 7d8f8389-730d-494e-a0af-5a91a3c99e17 2026-01-16 Warnings Exact identifier application number: M013 TENSION HEADACHE RELIEF ACETAMINOPHEN AND CAFFEINE WALGREENS 54aff6a0-2778-472f-90ba-375d6bce6ee8 2026-01-16 Warnings Exact identifier application number: M013 EXTRA STRENGTH HEADACHE RELIEF ACETAMINOPHEN, ASPIRIN, CAFFEINE WALGREENS 097fbab7-3886-4e75-b037-f03adcf3859f 2026-01-16 Warnings Exact identifier application number: M013 Pain Reliever ACETAMINOPHEN WALGREENS CO. bdb09e15-8e17-4987-99d0-bab8856a2109 2026-01-16 Warnings Exact identifier application number: M013 acetaminophen ACETAMINOPHEN HF Acquisition Co LLC, DBA HealthFirst 4870ff00-f727-814d-e063-6394a90a6c8e 2026-01-15 Warnings Exact identifier application number: M013 Aspirin ASPIRIN HyVee Inc 957b13a4-4086-459f-8fa0-9708b317fabe 2026-01-15 Warnings Exact identifier application number: M013 Unisom PM Pain Nighttime Sleep Aid and Pain Reliever ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE Chattem, Inc. 451daeeb-88a9-44b1-9a2d-1ff0b0ec41cb 2026-01-14 Warnings Exact identifier application number: M013
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 16103-366-05 16103036605 1 BOTTLE, PLASTIC in 1 CARTON (16103-366-05) / 36 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC 2007-08-22 0000-00-00 No No Current 16103-366-11 16103036611 1000 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (16103-366-11) 2007-08-22 0000-00-00 No No Current