Home NDC 68391-227-05 Aspirin
Product NDC 68391-227
Requested package NDC 68391-227-05
11-digit product format 683910227
Labeler code 68391
Product ID 68391-227_22501613-13a3-46c3-8baa-42ec3ced2f32
Type HUMAN OTC DRUG
Nonproprietary name Aspirin
Dosage form TABLET, COATED
Route ORAL
Labeler BJWC (Berkley & Jensen / BJ's)
Application part343
Marketing category OTC MONOGRAPH FINAL
Marketing start 2013-03-31
Marketing end 2024-03-31
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 0000-00-00
Current FDA listing Historical FDA.report record 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ASPIRIN ACTIVE INGREDIENT R16CO5Y76E ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)] 3 ASPIRIN ACTIVE MOIETY R16CO5Y76E ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)] 3 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)] 3 BROWN IRON OXIDE INACTIVE INGREDIENT 1N032N7MFO ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)] 3 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)] 3 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)] 3 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)] 3 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)] 3 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)] 3 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)] 3 METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) INACTIVE INGREDIENT 74G4R6TH13 ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)] 3 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)] 3 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)] 3 POTASSIUM HYDROXIDE INACTIVE INGREDIENT WZH3C48M4T ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)] 3 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)] 3 SHELLAC INACTIVE INGREDIENT 46N107B71O ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)] 3 SODIUM BICARBONATE INACTIVE INGREDIENT 8MDF5V39QO ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)] 3 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)] 3 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)] 3 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)] 3 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)] 3 WATER INACTIVE INGREDIENT 059QF0KO0R ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)] 3
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 68391-227-05 68391022705 1 BOTTLE, PLASTIC in 1 BOX (68391-227-05) > 500 TABLET, COATED in 1 BOTTLE, PLASTIC 2013-03-31 2024-03-31 No No Current