FDA.reportPublic FDA data

Back and Body

Product NDC
50844-413
11-digit product format
508440413
Labeler code
50844
Product ID
50844-413_e2623a15-74b3-4895-99a6-eec690b1c531
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin, Caffeine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
L.N.K. International, Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2004-04-12
Substance
ASPIRIN; CAFFEINE
Active strength
500; 32.5 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
2027-12-31
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
Back and Body
Brand name suffix
Extra Strength
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN500 mg/1
CAFFEINE32.5 mg/1

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
50844-413-08Back and BodyExtra Strength1 in 1 CARTONTABLET, FILM COATED113
50844-413-08Back and BodyExtra Strength24 in 1 BOTTLE, PLASTICTABLET, FILM COATED2413
50844-413-09Back and BodyExtra Strength20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2013
50844-413-09Back and BodyExtra Strength1 in 1 CARTONTABLET, FILM COATED113

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EEXTRA STRENGTH BACK AND BODY (ASPIRIN, CAFFEINE) CAPSULE [L.N.K. INTERNATIONAL, INC.]1
CAFFEINEACTIVE INGREDIENT3G6A5W338EEXTRA STRENGTH BACK AND BODY (ASPIRIN, CAFFEINE) CAPSULE [L.N.K. INTERNATIONAL, INC.]1
ASPIRINACTIVE MOIETYR16CO5Y76EEXTRA STRENGTH BACK AND BODY (ASPIRIN, CAFFEINE) CAPSULE [L.N.K. INTERNATIONAL, INC.]1
CAFFEINEACTIVE MOIETY3G6A5W338EEXTRA STRENGTH BACK AND BODY (ASPIRIN, CAFFEINE) CAPSULE [L.N.K. INTERNATIONAL, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOEXTRA STRENGTH BACK AND BODY (ASPIRIN, CAFFEINE) CAPSULE [L.N.K. INTERNATIONAL, INC.]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DEXTRA STRENGTH BACK AND BODY (ASPIRIN, CAFFEINE) CAPSULE [L.N.K. INTERNATIONAL, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AEXTRA STRENGTH BACK AND BODY (ASPIRIN, CAFFEINE) CAPSULE [L.N.K. INTERNATIONAL, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JEXTRA STRENGTH BACK AND BODY (ASPIRIN, CAFFEINE) CAPSULE [L.N.K. INTERNATIONAL, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJEXTRA STRENGTH BACK AND BODY (ASPIRIN, CAFFEINE) CAPSULE [L.N.K. INTERNATIONAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50844-413BACK AND BODY EXTRA STRENGTH (ASPIRIN, CAFFEINE) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]12Current NDC, Legacy NDC, 4 package rows20240921_6d254f3f-8223-4a6e-a3b2-f53f145ff3dc.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 27 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen Diphenhydramine HCLACETAMINOPHEN DIPHENHYDRAMINE HCLWALGREENS CO.d92d97a8-0ee3-1206-e053-2a95a90a72a82025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENSAM'S WEST INC0c8e7095-0806-4501-e063-6394a90a89aa2025-12-19WarningsExact identifier
application number: M013
Acetaminophen Diphenhydramine HCLACETAMINOPHEN DIPHENHYDRAMINE HCLWALGREEN CO.b3763182-2428-155a-e053-2995a90ab5782025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENWALGREENSe467b78e-9f23-5563-e053-2a95a90a586e2025-12-19WarningsExact identifier
application number: M013
Acetaminophen Diphenhydramine HCLACETAMINOPHEN DIPHENHYDRAMINE HCLWalgreensfd7c3250-35d4-494a-e053-6394a90a2db52025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCVS PHARMACY, INC1ddb8a2b-3081-3eda-e063-6294a90ab82b2025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCVS PHARMACY, INCb1307d52-10e6-46e1-e053-2995a90a03b62025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCVS PHARMACY, INCc2c6d6a1-b492-506d-e053-2995a90aac232025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENFAMILY DOLLARf8383108-0970-9f1e-e053-6294a90ad38f2025-12-19WarningsExact identifier
application number: M013
ACETAMINOPHEN 500 MGACETAMINOPHENNUVICARE LLC591ee107-e953-4982-b75f-13a0afd7c4ae2025-12-19WarningsExact identifier
application number: M013
Nuvicare Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINENUVICARE LLC3ede0fb6-c089-4253-9878-2b01c39e9c872025-12-19WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINNUVICARE LLC3a4aa3c7-b726-4303-8803-74196fa5637a2025-12-19WarningsExact identifier
application number: M013
ACETAMINOPHEN 500 MGACETAMINOPHENNUVICARE LLC95edf7bd-b6a7-4be5-9ad7-8748e7c2d06e2025-12-19WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINENUVICARE LLC32a5611b-9bf6-4850-a7ff-fa240da04f452025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENBETTER LIVING BRANDS LLC.ac0e96d0-746e-fb42-e053-2a95a90a19572025-12-18WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENBETTER LIVING BRANDS LLC.ac0e5dc0-96eb-47b2-e053-2995a90add0e2025-12-18WarningsExact identifier
application number: M013
Acetaminophen Diphenhydramine HClACETAMINOPHEN DIPHENHYDRAMINE HCLBETTER LIVING BRANDS LLC.ac0f8d5c-d200-1156-e053-2a95a90aece62025-12-18WarningsExact identifier
application number: M013
Pain and Fever ChildrensACETAMINOPHENCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDe55645ab-66f9-4160-8247-395bc5b027112025-12-18WarningsExact identifier
application number: M013
Dolex ForteACETAMINOPHEN, ASPIRIN, CAFFEINEPharmadel LLC3c2d90fc-130d-476c-e063-6294a90a8c152025-12-17WarningsExact identifier
application number: M013
CareOne Childrens AcetaminophenACETAMINOPHENAmerican Sales Company07bc6632-fabb-427d-81f3-c27c54caa6a02025-12-17WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702316aspirin 500 MG / caffeine 32.5 MG Oral TabletPSN6d254f3f-8223-4a6e-a3b2-f53f145ff3dc13
702316aspirin 500 MG / caffeine 32.5 MG Oral TabletSCD6d254f3f-8223-4a6e-a3b2-f53f145ff3dc13
702316ASA 500 MG / Caffeine 32.5 MG Oral TabletSY6d254f3f-8223-4a6e-a3b2-f53f145ff3dc13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50844-413-08508440413081 BOTTLE, PLASTIC in 1 CARTON (50844-413-08) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2004-04-120000-00-00NoNoCurrent
50844-413-09508440413091 BOTTLE, PLASTIC in 1 CARTON (50844-413-09) / 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2004-04-12NoNoCurrent