Home NDC 0591-3546-05 Butalbital, Aspirin, Caffeine and Codeine Phosphate
Product NDC 0591-3546
Requested package NDC 0591-3546-05
11-digit product format 005913546
Labeler code 0591
Product ID 0591-3546_ff179a8f-27fe-4c3b-8e3a-1ac069ad055d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Butalbital, Aspirin, Caffeine and Codeine Phosphate
Dosage form CAPSULE
Route ORAL
Labeler Actavis Pharma, Inc.
Application NDA019429
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2006-10-26
Marketing end 0000-00-00
Substance CODEINE PHOSPHATE; BUTALBITAL; CAFFEINE; ASPIRIN
Active strength 30 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes Full Opioid Agonists [MoA],Opioid Agonist [EPC],Barbiturates [CS],Barbiturate [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
DEA schedule CIII
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 · 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…
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 N019429-003 FIORINAL W/CODEINE ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 325MG;50MG;40MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1990-10-26
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 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1990-10-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1990-10-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1990-10-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL RLD 1990-10-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL RLD 1990-10-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL RLD 1990-10-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL RLD 1990-10-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL RLD 1990-10-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL RLD 1990-10-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL RLD 1990-10-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL RLD 1990-10-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL RLD 1990-10-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL RLD 1990-10-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL RLD 1990-10-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL RLD 1990-10-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL RLD 1990-10-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL RLD 1990-10-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1990-10-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1990-10-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1990-10-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1990-10-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1990-10-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1990-10-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1990-10-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1990-10-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1990-10-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1990-10-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1990-10-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1990-10-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL RLD 1990-10-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL RLD 1990-10-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL RLD 1990-10-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL RLD 1990-10-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL RLD 1990-10-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL RLD 1990-10-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL RLD 1990-10-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL RLD 1990-10-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL RLD 1990-10-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL RLD 1990-10-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL RLD 1990-10-26 f41ea6bd6efb…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ASPIRIN ACTIVE INGREDIENT R16CO5Y76E BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [ACTAVIS PHARMA, INC.] 9 BUTALBITAL ACTIVE INGREDIENT KHS0AZ4JVK BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [ACTAVIS PHARMA, INC.] 9 CAFFEINE ACTIVE INGREDIENT 3G6A5W338E BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [ACTAVIS PHARMA, INC.] 9 CODEINE PHOSPHATE ACTIVE INGREDIENT GSL05Y1MN6 BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [ACTAVIS PHARMA, INC.] 9 ASPIRIN ACTIVE MOIETY R16CO5Y76E BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [ACTAVIS PHARMA, INC.] 9 BUTALBITAL ACTIVE MOIETY KHS0AZ4JVK BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [ACTAVIS PHARMA, INC.] 9 CAFFEINE ACTIVE MOIETY 3G6A5W338E BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [ACTAVIS PHARMA, INC.] 9 CODEINE ANHYDROUS ACTIVE MOIETY UX6OWY2V7J BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [ACTAVIS PHARMA, INC.] 9 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [ACTAVIS PHARMA, INC.] 9 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [ACTAVIS PHARMA, INC.] 9 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [ACTAVIS PHARMA, INC.] 9 FD&C RED NO. 3 INACTIVE INGREDIENT PN2ZH5LOQY BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [ACTAVIS PHARMA, INC.] 9 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [ACTAVIS PHARMA, INC.] 9 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [ACTAVIS PHARMA, INC.] 9 GELATIN INACTIVE INGREDIENT 2G86QN327L BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [ACTAVIS PHARMA, INC.] 9 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [ACTAVIS PHARMA, INC.] 9 TALC INACTIVE INGREDIENT 7SEV7J4R1U BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [ACTAVIS PHARMA, INC.] 9 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [ACTAVIS PHARMA, INC.] 9 ASPIRIN ACTIVE INGREDIENT R16CO5Y76E BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 BUTALBITAL ACTIVE INGREDIENT KHS0AZ4JVK BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 CAFFEINE ACTIVE INGREDIENT 3G6A5W338E BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 CODEINE PHOSPHATE ACTIVE INGREDIENT GSL05Y1MN6 BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 ASPIRIN ACTIVE MOIETY R16CO5Y76E BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 BUTALBITAL ACTIVE MOIETY KHS0AZ4JVK BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 CAFFEINE ACTIVE MOIETY 3G6A5W338E BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 CODEINE ACTIVE MOIETY Q830PW7520 BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 FD&C RED NO. 3 INACTIVE INGREDIENT PN2ZH5LOQY BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1
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 0591-3546-05 00591354605 500 CAPSULE in 1 BOTTLE (0591-3546-05) 500 capsule 2006-10-26 0000-00-00 No No Current