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 1.

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2022-10-28 04:53 UTC2022-10A040387-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG/15ML;50MG/15ML;40MG/15MLSOLUTION / ORALRS2003-01-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040387-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG/15ML;50MG/15ML;40MG/15MLSOLUTION / ORALRS2003-01-31e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040387-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG/15ML;50MG/15ML;40MG/15MLSOLUTION / ORALRS2003-01-31cb3db0bc1861…

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

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Butalbital, Acetaminophen and CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEGenus Lifesciences Inc.5f603b0d-69e5-4c02-b6b3-b4705e243e9a2025-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040387
application number: ANDA040387