FDA.reportPublic FDA data

Bayer Back and Body

Product NDC
0280-2150
11-digit product format
002802150
Labeler code
0280
Product ID
0280-2150_32715f4e-2d90-9bff-e063-6394a90a4aab
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin,Caffeine
Dosage form
TABLET
Route
ORAL
Labeler
Bayer HealthCare LLC.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-01-12
Substance
ASPIRIN; CAFFEINE
Active strength
500; 35.5 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
Bayer Back and Body
Brand name suffix
Extra Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN500 mg/1
CAFFEINE35.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR16CO5Y76E, 3G6A5W338E

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
0280-2150-01Bayer Back and BodyExtra Strength1 in 1 CARTONTABLET17
0280-2150-01Bayer Back and BodyExtra Strength6 in 1 BOTTLE, PLASTICTABLET67
0280-2150-02Bayer Back and BodyExtra Strength200 in 1 BOTTLE, PLASTICTABLET2007
0280-2150-03Bayer Back and BodyExtra Strength250 in 1 BOTTLETABLET2507
0280-2150-10Bayer Back and BodyExtra Strength100 in 1 BOTTLE, PLASTICTABLET1007
0280-2150-10Bayer Back and BodyExtra Strength1 in 1 CARTONTABLET17
0280-2150-24Bayer Back and BodyExtra Strength24 in 1 BOTTLE, PLASTICTABLET247
0280-2150-24Bayer Back and BodyExtra Strength1 in 1 CARTONTABLET17
0280-2150-50Bayer Back and BodyExtra Strength50 in 1 BOTTLE, PLASTICTABLET507
0280-2150-50Bayer Back and BodyExtra Strength1 in 1 CARTONTABLET17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EBAYER BACK AND BODY EXTRA STRENGTH (ASPIRIN,CAFFEINE) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]1
CAFFEINEACTIVE INGREDIENT3G6A5W338EBAYER BACK AND BODY EXTRA STRENGTH (ASPIRIN,CAFFEINE) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]1
ASPIRINACTIVE MOIETYR16CO5Y76EBAYER BACK AND BODY EXTRA STRENGTH (ASPIRIN,CAFFEINE) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]1
CAFFEINEACTIVE MOIETY3G6A5W338EBAYER BACK AND BODY EXTRA STRENGTH (ASPIRIN,CAFFEINE) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933BAYER BACK AND BODY EXTRA STRENGTH (ASPIRIN,CAFFEINE) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZBAYER BACK AND BODY EXTRA STRENGTH (ASPIRIN,CAFFEINE) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BBAYER BACK AND BODY EXTRA STRENGTH (ASPIRIN,CAFFEINE) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBAYER BACK AND BODY EXTRA STRENGTH (ASPIRIN,CAFFEINE) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBAYER BACK AND BODY EXTRA STRENGTH (ASPIRIN,CAFFEINE) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]1
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MBAYER BACK AND BODY EXTRA STRENGTH (ASPIRIN,CAFFEINE) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BAYER BACK AND BODY EXTRA STRENGTH (ASPIRIN,CAFFEINE) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]1
SHELLACINACTIVE INGREDIENT46N107B71OBAYER BACK AND BODY EXTRA STRENGTH (ASPIRIN,CAFFEINE) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBAYER BACK AND BODY EXTRA STRENGTH (ASPIRIN,CAFFEINE) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBAYER BACK AND BODY EXTRA STRENGTH (ASPIRIN,CAFFEINE) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]1
TRIACETININACTIVE INGREDIENTXHX3C3X673BAYER BACK AND BODY EXTRA STRENGTH (ASPIRIN,CAFFEINE) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0280-2150BAYER BACK AND BODY EXTRA STRENGTH (ASPIRIN,CAFFEINE) TABLET [BAYER HEALTHCARE LLC.]7Current NDC, Legacy NDC, 10 package rows20250411_0c77c484-6caf-12ca-e054-00144ff88e88.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0280-2150-01002802150011 BOTTLE, PLASTIC in 1 CARTON (0280-2150-01) / 6 TABLET in 1 BOTTLE, PLASTIC2015-01-12NoNoHistorical
0280-2150-0200280215002200 TABLET in 1 BOTTLE, PLASTIC (0280-2150-02) 200 tablet2015-01-120000-00-00NoNoCurrent
0280-2150-0300280215003250 TABLET in 1 BOTTLE (0280-2150-03) 250 tablet2015-01-12NoNoHistorical
0280-2150-10002802150101 BOTTLE, PLASTIC in 1 CARTON (0280-2150-10) / 100 TABLET in 1 BOTTLE, PLASTIC2015-01-120000-00-00NoNoCurrent
0280-2150-24002802150241 BOTTLE, PLASTIC in 1 CARTON (0280-2150-24) / 24 TABLET in 1 BOTTLE, PLASTIC2015-01-120000-00-00NoNoCurrent
0280-2150-50002802150501 BOTTLE, PLASTIC in 1 CARTON (0280-2150-50) / 50 TABLET in 1 BOTTLE, PLASTIC2015-01-120000-00-00NoNoCurrent