Home NDC 81033-002 Acetaminophen
Product NDC 81033-002
11-digit product format 810330002
Labeler code 81033
Product ID 81033-002_c61a7995-69ee-6141-e053-2a95a90aae98
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form SOLUTION
Route ORAL
Labeler Kesin Pharma Corporation
Application part343
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2021-06-30
Marketing end 0000-00-00
Substance ACETAMINOPHEN
Active strength 160 mg/5mL
NDC exclude flag No
Listing certified through 2022-12-31
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 · 8 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 2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 81033-002-41 ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 81033-002-51 ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 81033-002-31 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 81033-002-41 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 81033-002-51 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 81033-002-31 367a005e9d99…383a685ebd0f…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 81033-002-31 2024-12-02 5mL, 10.15mL, 20.3mL, ACETAMINOPHEN oral solution 160mg per 5mL, 10.15mL 81033-002-41 2024-12-02 5mL, 10.15mL, 20.3mL, ACETAMINOPHEN oral solution 160mg per 5mL, 10.15mL 81033-002-51 2024-12-02 5mL, 10.15mL, 20.3mL, ACETAMINOPHEN oral solution 160mg per 5mL, 10.15mL 81033-002-31 2024-07-30 5mL, 10.15mL, 20.3mL, ACETAMINOPHEN oral solution 160mg per 5mL, 10.15mL 81033-002-41 2024-07-30 5mL, 10.15mL, 20.3mL, ACETAMINOPHEN oral solution 160mg per 5mL, 10.15mL 81033-002-51 2024-07-30 5mL, 10.15mL, 20.3mL, ACETAMINOPHEN oral solution 160mg per 5mL, 10.15mL
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 81033-002-05 Acetaminophen 5 mL in 1 CUP, UNIT-DOSE SOLUTION 5 6 81033-002-10 Acetaminophen 10.15 mL in 1 CUP, UNIT-DOSE SOLUTION 10.15 6 81033-002-20 Acetaminophen 20.3 mL in 1 CUP, UNIT-DOSE SOLUTION 20.3 6 81033-002-30 Acetaminophen 30 in 1 CARTON SOLUTION 30 6 81033-002-40 Acetaminophen 40 in 1 CARTON SOLUTION 40 6 81033-002-50 Acetaminophen 50 in 1 CARTON SOLUTION 50 6 81033-002-53 Acetaminophen 100 in 1 CARTON SOLUTION 100 6 81033-002-54 Acetaminophen 100 in 1 CASE SOLUTION 100 6 81033-002-55 Acetaminophen 100 in 1 CASE SOLUTION 100 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81033-002 ACETAMINOPHEN SOLUTION [KESIN PHARMA CORPORATION] 6 Legacy NDC, 9 package rows 20241207_c5b3c78c-9148-bf69-e053-2995a90aba65.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 81033-002-05 81033000205 5 mL in 1 CUP, UNIT-DOSE 5 ml Historical 81033-002-10 81033000210 10.15 mL in 1 CUP, UNIT-DOSE 10.15 ml Historical 81033-002-20 81033000220 20.3 mL in 1 CUP, UNIT-DOSE 20.3 ml Historical 81033-002-30 81033000230 30 in 1 CARTON Historical 81033-002-31 81033000231 8 CARTON in 1 CASE (81033-002-31) > 50 CUP, UNIT-DOSE in 1 CARTON (81033-002-30) > 20.3 mL in 1 CUP, UNIT-DOSE (81033-002-20) 8 carton 2021-06-30 0000-00-00 No No Current 81033-002-40 81033000240 40 in 1 CARTON Historical 81033-002-41 81033000241 8 CARTON in 1 CASE (81033-002-41) > 50 CUP, UNIT-DOSE in 1 CARTON (81033-002-40) > 10.15 mL in 1 CUP, UNIT-DOSE (81033-002-10) 8 carton 2021-06-30 0000-00-00 No No Current 81033-002-50 81033000250 50 in 1 CARTON Historical 81033-002-51 81033000251 8 CARTON in 1 CASE (81033-002-51) > 50 CUP, UNIT-DOSE in 1 CARTON (81033-002-50) > 5 mL in 1 CUP, UNIT-DOSE (81033-002-05) 8 carton 2021-06-30 0000-00-00 No No Current 81033-002-53 81033000253 100 in 1 CARTON Historical 81033-002-54 81033000254 100 in 1 CASE Historical 81033-002-55 81033000255 100 in 1 CASE Historical