Home NDC 0121-1008 Acetaminophen and Codeine Phosphate
Product NDC 0121-1008
11-digit product format 001211008
Labeler code 0121
Product ID 0121-1008_7cfdf5a3-ffd5-403b-8421-6275ca7cf02d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ACETAMINOPHEN and CODEINE PHOSPHATE
Dosage form SOLUTION
Route ORAL
Labeler PAI Holdings, LLC dba PAI Pharma
Application ANDA087508
Marketing category ANDA
Marketing start 1981-08-21
Substance ACETAMINOPHEN; CODEINE PHOSPHATE
Active strength 300; 30 mg/12.5mL; mg/12.5mL
Pharmacologic classes Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule CV
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 · 16 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0121-1008-00 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 0121-1008-00 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 0121-1008-00 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 0121-1008-00 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 0121-1008-00 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 0121-1008-00 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 0121-1008-00 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product Y Unknown FDA exclusion code: Y 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 0121-1008-00 Y Unknown FDA exclusion code: Y 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A087508-001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 120MG/5ML;12MG/5ML SOLUTION / ORAL RS, Approved before 1982
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A087508-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 120MG/5ML;12MG/5ML SOLUTION / ORAL RS, Approved before 1982 84e616aacf4f…2026-08-18 06:07:40 2026-07 A087508-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 120MG/5ML;12MG/5ML SOLUTION / ORAL RS, Approved before 1982 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A087508-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 120MG/5ML;12MG/5ML SOLUTION / ORAL RS, Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A087508-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 120MG/5ML;12MG/5ML SOLUTION / ORAL RS, Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A087508-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 120MG/5ML;12MG/5ML SOLUTION / ORAL RS, Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A087508-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 120MG/5ML;12MG/5ML SOLUTION / ORAL RS, Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A087508-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 120MG/5ML;12MG/5ML SOLUTION / ORAL AA RS, Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A087508-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 120MG/5ML;12MG/5ML SOLUTION / ORAL AA RS, Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A087508-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 120MG/5ML;12MG/5ML SOLUTION / ORAL AA RS, Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A087508-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 120MG/5ML;12MG/5ML SOLUTION / ORAL AA RS, Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A087508-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 120MG/5ML;12MG/5ML SOLUTION / ORAL AA RS, Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A087508-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 120MG/5ML;12MG/5ML SOLUTION / ORAL AA RS, Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A087508-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 120MG/5ML;12MG/5ML SOLUTION / ORAL AA RS, Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A087508-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 120MG/5ML;12MG/5ML SOLUTION / ORAL AA RS, Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A087508-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 120MG/5ML;12MG/5ML SOLUTION / ORAL AA RS, Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A087508-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 120MG/5ML;12MG/5ML SOLUTION / ORAL AA RS, Approved before 1982 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A087508-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 120MG/5ML;12MG/5ML SOLUTION / ORAL AA RS, Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A087508-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 120MG/5ML;12MG/5ML SOLUTION / ORAL AA RS, Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A087508-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 120MG/5ML;12MG/5ML SOLUTION / ORAL AA RS, Approved before 1982 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A087508-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 120MG/5ML;12MG/5ML SOLUTION / ORAL AA RS, Approved before 1982 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A087508-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 120MG/5ML;12MG/5ML SOLUTION / ORAL AA RS, Approved before 1982 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A087508-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 120MG/5ML;12MG/5ML SOLUTION / ORAL AA RS, Approved before 1982 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A087508-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 120MG/5ML;12MG/5ML SOLUTION / ORAL AA RS, Approved before 1982 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A087508-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 120MG/5ML;12MG/5ML SOLUTION / ORAL AA RS, Approved before 1982 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A087508-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 120MG/5ML;12MG/5ML SOLUTION / ORAL AA RS, Approved before 1982 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A087508-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 120MG/5ML;12MG/5ML SOLUTION / ORAL AA RS, Approved before 1982 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A087508-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 120MG/5ML;12MG/5ML SOLUTION / ORAL AA RS, Approved before 1982 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A087508-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 120MG/5ML;12MG/5ML SOLUTION / ORAL AA RS, Approved before 1982 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A087508-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 120MG/5ML;12MG/5ML SOLUTION / ORAL AA RS, Approved before 1982 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A087508-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 120MG/5ML;12MG/5ML SOLUTION / ORAL AA RS, Approved before 1982 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A087508-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 120MG/5ML;12MG/5ML SOLUTION / ORAL AA RS, Approved before 1982 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A087508-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 120MG/5ML;12MG/5ML SOLUTION / ORAL AA RS, Approved before 1982 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A087508-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 120MG/5ML;12MG/5ML SOLUTION / ORAL AA RS, Approved before 1982 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A087508-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 120MG/5ML;12MG/5ML SOLUTION / ORAL AA RS, Approved before 1982 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A087508-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 120MG/5ML;12MG/5ML SOLUTION / ORAL AA RS, Approved before 1982 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A087508-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 120MG/5ML;12MG/5ML SOLUTION / ORAL AA RS, Approved before 1982 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A087508-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 120MG/5ML;12MG/5ML SOLUTION / ORAL AA RS, Approved before 1982 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A087508-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 120MG/5ML;12MG/5ML SOLUTION / ORAL AA RS, Approved before 1982 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A087508-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 120MG/5ML;12MG/5ML SOLUTION / ORAL AA RS, Approved before 1982 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A087508-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 120MG/5ML;12MG/5ML SOLUTION / ORAL AA RS, Approved before 1982 f41ea6bd6efb…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Acetaminophen and Codeine Phosphate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 300 mg/12.5mL CODEINE PHOSPHATE 30 mg/12.5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup GSL05Y1MN6 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 993755 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 0121-1008-12 Acetaminophen and Codeine Phosphate 12.5 mL in 1 CUP, UNIT-DOSE SOLUTION 12.5 31 0121-1008-40 Acetaminophen and Codeine Phosphate 40 in 1 CASE SOLUTION 40 31 0121-1008-40 Acetaminophen and Codeine Phosphate 10 in 1 TRAY SOLUTION 10 31
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 3 CODEINE PHOSPHATE ACTIVE INGREDIENT GSL05Y1MN6 ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 3 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 3 CODEINE ACTIVE MOIETY Q830PW7520 ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 3 ALCOHOL INACTIVE INGREDIENT 3K9958V90M ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 3 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 3 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 3 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 3 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 3 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 3 SUCROSE INACTIVE INGREDIENT C151H8M554 ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 3 WATER INACTIVE INGREDIENT 059QF0KO0R ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0121-1008 ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA] 31 Current NDC, 3 package rows 20241006_95ac6875-6b14-4cde-8efb-80704e39b8d8.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 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0121-1008-12 00121100812 12.5 mL in 1 CUP, UNIT-DOSE (0121-1008-12) 12.5 ml 2024-10-07 No No Historical 0121-1008-40 00121100840 40 TRAY in 1 CASE (0121-1008-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 12.5 mL in 1 CUP, UNIT-DOSE (0121-1008-12) 40 tray 1981-08-21 No No Current