FDA.reportPublic FDA data

Butalbital, Acetaminophen and Caffeine

Product NDC
46672-633
11-digit product format
466720633
Labeler code
46672
Product ID
46672-633_aefaf972-392e-400c-e053-2a95a90aeab0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
butalbital, acetaminophen and caffeine
Dosage form
SYRUP
Route
ORAL
Labeler
Mikart, LLC
Application
ANDA040387
Marketing category
ANDA
Marketing start
2003-01-31
Marketing end
0000-00-00
Substance
BUTALBITAL; ACETAMINOPHEN; CAFFEINE
Active strength
50 mg/15mL; mg/15mL; mg/15mL
Pharmacologic classes
Barbiturates [CS],Barbiturate [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040387-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINEACETAMINOPHEN; BUTALBITAL; CAFFEINE325MG/15ML;50MG/15ML;40MG/15MLSOLUTION / ORALRS2003-01-31

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A040387-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG/15ML;50MG/15ML;40MG/15MLSOLUTION / ORALRS2003-01-31c2088c7a36db…
2026-09-14 22:38:342026-08A040387-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG/15ML;50MG/15ML;40MG/15MLSOLUTION / ORALRS2003-01-3184e616aacf4f…
2026-08-18 06:07:402026-07A040387-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG/15ML;50MG/15ML;40MG/15MLSOLUTION / ORALRS2003-01-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040387-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG/15ML;50MG/15ML;40MG/15MLSOLUTION / ORALRS2003-01-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040387-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG/15ML;50MG/15ML;40MG/15MLSOLUTION / ORALRS2003-01-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040387-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG/15ML;50MG/15ML;40MG/15MLSOLUTION / ORALRS2003-01-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040387-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG/15ML;50MG/15ML;40MG/15MLSOLUTION / ORALRS2003-01-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040387-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG/15ML;50MG/15ML;40MG/15MLSOLUTION / ORALRS2003-01-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040387-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG/15ML;50MG/15ML;40MG/15MLSOLUTION / ORALRS2003-01-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040387-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG/15ML;50MG/15ML;40MG/15MLSOLUTION / ORALRS2003-01-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040387-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG/15ML;50MG/15ML;40MG/15MLSOLUTION / ORALRS2003-01-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040387-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG/15ML;50MG/15ML;40MG/15MLSOLUTION / ORALRS2003-01-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040387-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG/15ML;50MG/15ML;40MG/15MLSOLUTION / ORALRS2003-01-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040387-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG/15ML;50MG/15ML;40MG/15MLSOLUTION / ORALRS2003-01-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040387-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG/15ML;50MG/15ML;40MG/15MLSOLUTION / ORALRS2003-01-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040387-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG/15ML;50MG/15ML;40MG/15MLSOLUTION / ORALRS2003-01-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040387-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG/15ML;50MG/15ML;40MG/15MLSOLUTION / ORALRS2003-01-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040387-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG/15ML;50MG/15ML;40MG/15MLSOLUTION / ORALRS2003-01-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040387-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG/15ML;50MG/15ML;40MG/15MLSOLUTION / ORALRS2003-01-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040387-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG/15ML;50MG/15ML;40MG/15MLSOLUTION / ORALRS2003-01-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040387-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG/15ML;50MG/15ML;40MG/15MLSOLUTION / ORALRS2003-01-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040387-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG/15ML;50MG/15ML;40MG/15MLSOLUTION / ORALRS2003-01-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040387-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG/15ML;50MG/15ML;40MG/15MLSOLUTION / ORALRS2003-01-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040387-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG/15ML;50MG/15ML;40MG/15MLSOLUTION / ORALRS2003-01-3187673890dc5c…
2021-03-12 10:30 UTC2021-03A040387-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG/15ML;50MG/15ML;40MG/15MLSOLUTION / ORALRS2003-01-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040387-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG/15ML;50MG/15ML;40MG/15MLSOLUTION / ORALRS2003-01-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040387-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG/15ML;50MG/15ML;40MG/15MLSOLUTION / ORALRS2003-01-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040387-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG/15ML;50MG/15ML;40MG/15MLSOLUTION / ORALRS2003-01-313f01610625f2…
2019-09-15 20:21 UTC2019-09A040387-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG/15ML;50MG/15ML;40MG/15MLSOLUTION / ORALRS2003-01-31b00525d2431f…
2019-07-19 19:46 UTC2019-07A040387-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG/15ML;50MG/15ML;40MG/15MLSOLUTION / ORALRS2003-01-31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040387-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG/15ML;50MG/15ML;40MG/15MLSOLUTION / ORALRS2003-01-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040387-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG/15ML;50MG/15ML;40MG/15MLSOLUTION / ORALRS2003-01-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040387-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG/15ML;50MG/15ML;40MG/15MLSOLUTION / ORALRS2003-01-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040387-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG/15ML;50MG/15ML;40MG/15MLSOLUTION / ORALRS2003-01-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040387-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG/15ML;50MG/15ML;40MG/15MLSOLUTION / ORALRS2003-01-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040387-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG/15ML;50MG/15ML;40MG/15MLSOLUTION / ORALRS2003-01-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040387-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG/15ML;50MG/15ML;40MG/15MLSOLUTION / ORALRS2003-01-313f0d92c62455…
2023-05-13 08:27 UTC2023-05A040387-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG/15ML;50MG/15ML;40MG/15MLSOLUTION / ORALRS2003-01-31053a50430f4f…
2023-01-26 05:58 UTC2023-01A040387-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG/15ML;50MG/15ML;40MG/15MLSOLUTION / ORALRS2003-01-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040387-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG/15ML;50MG/15ML;40MG/15MLSOLUTION / ORALRS2003-01-313a93d1ddd44b…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DBUTALBITAL, ACETAMINOPHEN AND CAFFEINE SYRUP [MIKART, INC.]3
BUTALBITALACTIVE INGREDIENTKHS0AZ4JVKBUTALBITAL, ACETAMINOPHEN AND CAFFEINE SYRUP [MIKART, INC.]3
CAFFEINEACTIVE INGREDIENT3G6A5W338EBUTALBITAL, ACETAMINOPHEN AND CAFFEINE SYRUP [MIKART, INC.]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DBUTALBITAL, ACETAMINOPHEN AND CAFFEINE SYRUP [MIKART, INC.]3
BUTALBITALACTIVE MOIETYKHS0AZ4JVKBUTALBITAL, ACETAMINOPHEN AND CAFFEINE SYRUP [MIKART, INC.]3
CAFFEINEACTIVE MOIETY3G6A5W338EBUTALBITAL, ACETAMINOPHEN AND CAFFEINE SYRUP [MIKART, INC.]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MBUTALBITAL, ACETAMINOPHEN AND CAFFEINE SYRUP [MIKART, INC.]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLBUTALBITAL, ACETAMINOPHEN AND CAFFEINE SYRUP [MIKART, INC.]3
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2BUTALBITAL, ACETAMINOPHEN AND CAFFEINE SYRUP [MIKART, INC.]3
ETHYL MALTOLINACTIVE INGREDIENTL6Q8K29L05BUTALBITAL, ACETAMINOPHEN AND CAFFEINE SYRUP [MIKART, INC.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BUTALBITAL, ACETAMINOPHEN AND CAFFEINE SYRUP [MIKART, INC.]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBUTALBITAL, ACETAMINOPHEN AND CAFFEINE SYRUP [MIKART, INC.]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TBUTALBITAL, ACETAMINOPHEN AND CAFFEINE SYRUP [MIKART, INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BUTALBITAL, ACETAMINOPHEN AND CAFFEINE SYRUP [MIKART, INC.]3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHBUTALBITAL, ACETAMINOPHEN AND CAFFEINE SYRUP [MIKART, INC.]3
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYBUTALBITAL, ACETAMINOPHEN AND CAFFEINE SYRUP [MIKART, INC.]3
SORBITOLINACTIVE INGREDIENT506T60A25RBUTALBITAL, ACETAMINOPHEN AND CAFFEINE SYRUP [MIKART, INC.]3
SUCROSEINACTIVE INGREDIENTC151H8M554BUTALBITAL, ACETAMINOPHEN AND CAFFEINE SYRUP [MIKART, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RBUTALBITAL, ACETAMINOPHEN AND CAFFEINE SYRUP [MIKART, INC.]3