Home NDC 16103-366-11 Low Dose Aspirin
Product NDC 16103-366
Requested package NDC 16103-366-11
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 16103-366 16103-366-11 I Inactivated by FDA excluded / ndc_excluded.zip e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 16103-366 16103-366-11 I Inactivated by FDA excluded / ndc_excluded.zip 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 1 of 83 · 1,657 matching rows.
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 16103-366-11 16103036611 1000 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (16103-366-11) 2007-08-22 0000-00-00 No No Current