FDA.reportPublic FDA data

EXTRA PAIN RELIEF

Product NDC
49483-370
11-digit product format
494830370
Labeler code
49483
Product ID
49483-370_39a1157a-bfc7-63f5-e063-6394a90a9bba
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, ASPIRIN AND CAFFEINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
TIME CAP LABS
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-11-01
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

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
EXTRA PAIN RELIEF
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
R16CO5Y76EInternal UNII lookup
3G6A5W338EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308297Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
59482917-f80b-4bed-9218-068b35366eb3Available 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
49483-370-00EXTRA PAIN RELIEF20000 in 1 CARTONTABLET, FILM COATED200008
49483-370-01EXTRA PAIN RELIEF100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1008
49483-370-20EXTRA PAIN RELIEF200 in 1 BOTTLE, PLASTICTABLET, FILM COATED2008
49483-370-31EXTRA PAIN RELIEF300 in 1 BOTTLETABLET, FILM COATED3008
49483-370-42EXTRA PAIN RELIEF1 in 1 CARTONTABLET, FILM COATED18
49483-370-42EXTRA PAIN RELIEF24 in 1 BOTTLETABLET, FILM COATED248

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DEXTRA PAIN RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [TIME CAP LABS]1
ASPIRINACTIVE INGREDIENTR16CO5Y76EEXTRA PAIN RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [TIME CAP LABS]1
CAFFEINEACTIVE INGREDIENT3G6A5W338EEXTRA PAIN RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [TIME CAP LABS]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DEXTRA PAIN RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [TIME CAP LABS]1
ASPIRINACTIVE MOIETYR16CO5Y76EEXTRA PAIN RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [TIME CAP LABS]1
CAFFEINEACTIVE MOIETY3G6A5W338EEXTRA PAIN RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [TIME CAP LABS]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZEXTRA PAIN RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [TIME CAP LABS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UEXTRA PAIN RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [TIME CAP LABS]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4EXTRA PAIN RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [TIME CAP LABS]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOEXTRA PAIN RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [TIME CAP LABS]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPEXTRA PAIN RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [TIME CAP LABS]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EEXTRA PAIN RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [TIME CAP LABS]1
SODIUM STARCH GLYCOLATE TYPE A CORNINACTIVE INGREDIENTAG9B65PV6BEXTRA PAIN RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [TIME CAP LABS]1
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJEXTRA PAIN RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [TIME CAP LABS]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APEXTRA PAIN RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [TIME CAP LABS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEXTRA PAIN RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [TIME CAP LABS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49483-370EXTRA PAIN RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [TIME CAP LABS]7Current NDC, Legacy NDC, 6 package rows20240316_59482917-f80b-4bed-9218-068b35366eb3.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 79 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain Relief PM Extra StrengthACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MGAllegiant Health423a8445-964c-4cdb-889a-f391ca5253e72018-12-31WarningsExact identifier
application number: M013
Cold Multi-Symptom Night-timeACETAMINOPHEN,CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCIAllegiant Health3f020cf2-6011-4216-9b39-0b3dc5f0749c2018-12-26WarningsExact identifier
application number: M013
Aspirin ChewableASPIRIN 81 MGAllegiant Health92b8637b-03a9-461f-b2f6-6eddaa2149532018-12-21WarningsExact identifier
application number: M013
Sinus Headache PEMaximum Strength Non-Drowsy Maximum Strength Non-DrowsyACETAMINOPHEN AND PHENYLEPHRINE HCLAllegiant Healthb04b96e0-d99b-48d1-b8b8-e2fdd8dd3f5f2018-12-21WarningsExact identifier
application number: M013
Clear Choice Regular Strength Pain RelieverACETAMINOPHENAthlete's Needs, Inc.d0d9fda5-5eba-4d51-b505-e93a2ae0bdd72018-12-11WarningsExact identifier
application number: M013
ASPIRIN Enteric CoatedASPIRIN 81 MGAllegiant Health5910a882-eb40-440f-8a30-c21fbce9050e2018-11-07WarningsExact identifier
application number: M013
AspirinASPIRIN 325 MGAllegiant Health88b54062-8b3d-4024-a957-62b3255184b92018-11-07WarningsExact identifier
application number: M013
Aspirin Enteric CoatedASPIRIN 81 MGAllegiant Health3ca60fa3-0a0c-4b3e-a0a2-da527ccf4fe52018-11-07WarningsExact identifier
application number: M013
Tension Headache ReliefTENSION HEADACHE RELIEFAllegiant Healthb431a1a3-39c4-4d6c-afdc-c8b017ad89da2017-11-16WarningsExact identifier
application number: M013
SED-MAXACETAMINOPHEN 500 MG WITH CAFFEINE 65MGCommand Brands, LLC4920a0e9-6f88-4df0-8657-77c95a3b96172017-01-19WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletPSN59482917-f80b-4bed-9218-068b35366eb38
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletSCD59482917-f80b-4bed-9218-068b35366eb38
308297APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral TabletSY59482917-f80b-4bed-9218-068b35366eb38

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49483-370-004948303700020000 TABLET, FILM COATED in 1 CARTON (49483-370-00) 2016-02-220000-00-00NoNoCurrent
49483-370-0149483037001100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-370-01) 2021-07-160000-00-00NoNoCurrent
49483-370-2049483037020200 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-370-20) 2013-11-010000-00-00NoNoCurrent
49483-370-3149483037031300 TABLET, FILM COATED in 1 BOTTLE (49483-370-31) 2024-03-15NoNoCurrent
49483-370-42494830370421 BOTTLE in 1 CARTON (49483-370-42) / 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-07-160000-00-00NoNoCurrent