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
CAFFEINE; ASPIRIN
Active strength
35.5; 500 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

Reported adverse events (FAERS/openFDA)#

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

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
CAFFEINE35.5 mg/1
ASPIRIN500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3G6A5W338EInternal UNII lookup
R16CO5Y76EInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0c77c484-6caf-12ca-e054-00144ff88e88Available on FDA.report

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

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 73 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PANADOL ExtraACETAMINOPHEN AND CAFFEINEHaleon US Holdings LLCe5c2d88a-d903-4ca0-b895-f27e791dfc4e2024-02-06WarningsExact identifier
application number: M013
PANADOL Extra StrengthACETAMINOPHENHaleon US Holdings LLCb2fe7f47-1a2e-40ee-8f8f-38f2028dce1b2024-02-06WarningsExact identifier
application number: M013
PANADOL Extra StrengthACETAMINOPHENHaleon US Holdings LLC9d384e88-5c11-4600-ac6c-a383715701382024-02-06WarningsExact identifier
application number: M013
PANADOLACETAMINOPHENHaleon US Holdings LLC95801755-db54-4ad7-bec1-52671914f6ca2024-02-06WarningsExact identifier
application number: M013
PANADOL PMACETAMINOPHEN AND DIPHENHYDRAMINE HCLHaleon US Holdings LLC01e7dddb-755c-4745-b701-edcdb62090642024-02-06Warnings, Adverse reactionsExact identifier
application number: M013
PANADOL PMACETAMINOPHEN AND DIPHENHYDRAMINE HCLHaleon US Holdings LLCfe7cd1f2-9b00-4ded-99c2-8a152c71093c2024-02-06Warnings, Adverse reactionsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENAptaPharma Inc.9064943f-836f-4853-b6f2-2c4879941eeb2024-02-02WarningsExact identifier
application number: M013
Quality Choice Effervescent Pain ReliefASPIRINCHAIN DRUG MARKETING ASSOCIATION, INC.079af5d7-1be8-2a93-e063-6294a90a496d2024-02-01WarningsExact identifier
application number: M013
MEDI-FIRST Non-AspirinACETAMINOPHENProficient Rx LP4c84948d-3a95-4c53-8529-7e7b9d8bb6df2024-02-01WarningsExact identifier
application number: M013
PharbetolACETAMINOPHENProficient Rx LP9c7d65e4-df2f-47c1-a185-66aaf19aad2b2024-02-01WarningsExact identifier
application number: M013
Childrens AcetaminophenACETAMINOPHENProficient Rx LP57e4820c-b4eb-442e-9c49-93eedfbc5e5e2024-02-01WarningsExact identifier
application number: M013
good sense aspirinASPIRINProficient Rx LP73013074-9c6e-43c7-acde-4d9d8ed0133d2024-02-01WarningsExact identifier
application number: M013
MEDIQUE APAP Extra StrengthACETAMINOPHENProficient Rx LPc466a07f-2339-4cf5-8377-e0f109649c522024-02-01WarningsExact identifier
application number: M013
Percogesic Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINEMedtech Products Inc.2c5f1140-fb83-42c9-b0b1-5e2bd69340bb2024-02-01WarningsExact identifier
application number: M013
aspirinASPIRINProficient Rx LP3c7783a7-2b28-4968-b766-0a49dc70ce6d2024-02-01WarningsExact identifier
application number: M013
Regular Strength Pain ReliefACETAMINOPHENNuCare Pharmaceuticals,Inc.102bdcde-cb90-f248-e063-6394a90aac792024-01-30WarningsExact identifier
application number: M013
Excedrin Extra Strength HeadacheACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINEHaleon US Holdings LLC61802b27-c9ec-4386-9d44-45e8b1e558b72024-01-28WarningsExact identifier
application number: M013
AGRIFENACETAMINOPHEN, ASPIRIN, CAFFEINEOPMX LLC0fde22da-cdfc-36cc-e063-6294a90a38852024-01-26WarningsExact identifier
application number: M013
DOLODOLACETAMINOPHEN, ASPIRIN, CAFFEINEOPMX LLCe80536f1-92cc-5bb3-e053-2995a90a95402024-01-26WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINBryant Ranch Prepackd913d11f-c7a1-49d2-a2d3-9a29fc0328062024-01-18WarningsExact identifier
application number: M013

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, PLASTIC2015-01-12NoNoCurrent
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 tablet2015-01-12NoNoCurrent
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