FDA.reportPublic FDA data

ACETAMINOPHEN ASPIRIN AND CAFFEINE

Product NDC
21130-074
11-digit product format
211300074
Labeler code
21130
Product ID
21130-074_068e2ba0-2db2-4c12-ad9e-47a7130c2a22
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, aspirin and caffeine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Better Living Brands, LLC
Application
ANDA211695
Marketing category
ANDA
Marketing start
2023-08-11
Substance
ACETAMINOPHEN; ASPIRIN; CAFFEINE
Active strength
250; 250; 65 mg/1; mg/1; mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ACETAMINOPHEN ASPIRIN AND CAFFEINE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN250 mg/1
ASPIRIN250 mg/1
CAFFEINE65 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, R16CO5Y76E, 3G6A5W338E
Rxcui308297

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-074-07ACETAMINOPHEN ASPIRIN AND CAFFEINE1 in 1 CARTONTABLET, FILM COATED12
21130-074-07ACETAMINOPHEN ASPIRIN AND CAFFEINE24 in 1 BOTTLETABLET, FILM COATED242
21130-074-14ACETAMINOPHEN ASPIRIN AND CAFFEINE1 in 1 CARTONTABLET, FILM COATED12
21130-074-14ACETAMINOPHEN ASPIRIN AND CAFFEINE50 in 1 BOTTLETABLET, FILM COATED502
21130-074-21ACETAMINOPHEN ASPIRIN AND CAFFEINE100 in 1 BOTTLETABLET, FILM COATED1002
21130-074-21ACETAMINOPHEN ASPIRIN AND CAFFEINE1 in 1 CARTONTABLET, FILM COATED12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-074ACETAMINOPHEN ASPIRIN AND CAFFEINE (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]2Current NDC, 6 package rows20230818_f8050cae-8619-f49b-e053-6294a90ad9e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletPSNf8050cae-8619-f49b-e053-6294a90ad9e62
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletSCDf8050cae-8619-f49b-e053-6294a90ad9e62
308297APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral TabletSYf8050cae-8619-f49b-e053-6294a90ad9e62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
21130-074-07211300074071 BOTTLE in 1 CARTON (21130-074-07) / 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2023-08-11NoNoCurrent
21130-074-14211300074141 BOTTLE in 1 CARTON (21130-074-14) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2023-08-11NoNoCurrent
21130-074-21211300074211 BOTTLE in 1 CARTON (21130-074-21) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2023-08-11NoNoCurrent