FDA.reportPublic FDA data

good sense pain and fever

Product NDC
0113-0946
11-digit product format
001130946
Labeler code
0113
Product ID
0113-0946_033dff7b-79d7-4655-9e46-561905b64129
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
L. Perrigo Company
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-11-08
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
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
good sense pain and fever
Brand name suffix
infants
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN160 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
307668Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7b4c7e4c-1536-45ab-a59b-4d5dd8eb2eb4Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0113-0946-10good sense pain and feverinfants1 in 1 CARTONSUSPENSION15
0113-0946-10good sense pain and feverinfants30 mL in 1 BOTTLESUSPENSION305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0946-10ML - Milliliter0113-0946eebbddd5-02cf-4713-9dfc-55412f9b2ece12018-02-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DGOOD SENSE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [L. PERRIGO COMPANY]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DGOOD SENSE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [L. PERRIGO COMPANY]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLGOOD SENSE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [L. PERRIGO COMPANY]3
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8GOOD SENSE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [L. PERRIGO COMPANY]3
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505GOOD SENSE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [L. PERRIGO COMPANY]3
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311GOOD SENSE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [L. PERRIGO COMPANY]3
CARRAGEENANINACTIVE INGREDIENT5C69YCD2YJGOOD SENSE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [L. PERRIGO COMPANY]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGOOD SENSE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [L. PERRIGO COMPANY]3
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LGOOD SENSE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [L. PERRIGO COMPANY]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDGOOD SENSE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [L. PERRIGO COMPANY]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXGOOD SENSE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [L. PERRIGO COMPANY]3
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SGOOD SENSE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [L. PERRIGO COMPANY]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GOOD SENSE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [L. PERRIGO COMPANY]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUGOOD SENSE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [L. PERRIGO COMPANY]3
SODIUM PHOSPHATE, TRIBASICINACTIVE INGREDIENTA752Q30A6XGOOD SENSE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [L. PERRIGO COMPANY]3
SORBITOLINACTIVE INGREDIENT506T60A25RGOOD SENSE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [L. PERRIGO COMPANY]3
WATERINACTIVE INGREDIENT059QF0KO0RGOOD SENSE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [L. PERRIGO COMPANY]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0946GOOD SENSE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [L. PERRIGO COMPANY]5Current NDC, Legacy NDC, 2 package rows20240524_7b4c7e4c-1536-45ab-a59b-4d5dd8eb2eb4.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 7 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
INFANTS PAIN AND FEVERACETAMINOPHENAmazon.com Services LLC112076c4-cac2-45ab-9c77-5573edae71802026-07-10WarningsExact identifier
application number: M013
AspirinASPIRINWal-Mart Stores Inc8ae16aa2-54bc-4c1a-aa36-93524199a67b2026-07-09WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENWildman Business Group943c8f49-e65e-40bc-b364-3274df4d21a22026-07-09WarningsExact identifier
application number: M013
Aspirin Regular StrengthASPIRINFOODHOLD U.S.A., LLC9e09b4fb-e015-45ea-8b1c-27faf65572aa2026-07-09WarningsExact identifier
application number: M013
Tension Headache ReliefACETAMINOPHEN, CAFFEINEWalgreen Companyf13fb7e9-50ea-4e2c-a442-38b1b5b315d72026-07-09WarningsExact identifier
application number: M013
Acetaminophen 500 Pyrilamine Maleate 15 and Caffeine 60ACETAMINOPHEN 500MG PYRILAMINE MALEATE 15MG AND CAFFEINE 60MG TABLETSHealth Pharma USA LLC34eb8a9b-d0ee-13e8-e063-6294a90a2fef2026-07-08WarningsExact identifier
application number: M013
Acetaminophen 250 mg Aspirin 250 mg Caffeine 65 mgACETAMINOPHEN 250 MG ASPIRIN 250 MG CAFFEINE 65 MGHealth Pharma USA LLC3590d417-272b-ae4d-e063-6394a90a5dc62026-07-08WarningsExact identifier
application number: M013
GOODMEDS EXTRA STRENGTH PAIN RELIEF ACETAMINOPHENACETAMINOPHENCabinet Health P.B.C.88884253-5a79-4ac1-b8ce-03966d8b509d2026-07-08WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENHealth Pharma USA LLC671adabe-5f82-4599-a133-3f67ccb340792026-07-07WarningsExact identifier
application number: M013
Pain Reliever PlusACETAMINOPHEN, ASPIRIN, CAFFEINERugby Laboratoriesc3df1652-96a8-6043-e053-2995a90a2d262026-07-07WarningsExact identifier
application number: M013
Rapidol AspirinASPIRINPharmadel LLC00d9ab0d-ff25-784f-e063-6294a90a84972026-07-06WarningsExact identifier
application number: M013
AspirinASPIRINTrifecta Pharmaceuticals USA LLC227cefca-acc4-41d0-e063-6394a90a35b92026-07-06WarningsExact identifier
application number: M013
Extra Strength Pain AidACETAMINOPHEN, ASPIRIN, CAFFEINEHi-Tech Nutaceuticals, LLCa39e4b99-700d-0f5c-e053-2a95a90a6bd32026-07-06WarningsExact identifier
application number: M013
Nighttime Sleep AidACETAMINOPHEN, DIPHENHYDRAMINEHi-Tech Nutraceuticals, LLCa39e2bd6-3d0a-642b-e053-2995a90a42a02026-07-06WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENHi-Tech Nutraceuticals, LLCa36be487-7a36-550f-e053-2a95a90a95c12026-07-06WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENHi-Tech Nutraceuticals, LLCa39c524e-c131-d7fb-e053-2995a90a785b2026-07-06WarningsExact identifier
application number: M013
PAIN RELIEVERASPIRIN 81 MGHealth Pharma USA, LLCd60aed37-3a9e-46d1-e053-2995a90a1d1f2026-07-06WarningsExact identifier
application number: M013
Tylenol PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDESelect Consumer Group55d0dceb-c9a9-778e-e063-6294a90a2ad72026-07-04WarningsExact identifier
application number: M013
Bayer Genuine AspirinASPIRINSelect Consumer Group3ca776c2-47ed-5107-e063-6394a90ac5df2026-07-03WarningsExact identifier
application number: M013
AspirinASPIRINRugby Laboratoriesf7ca9f4a-f8ef-46d2-9536-b69541e6653d2026-07-02WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN7b4c7e4c-1536-45ab-a59b-4d5dd8eb2eb45
307668acetaminophen 32 MG/ML Oral SuspensionSCD7b4c7e4c-1536-45ab-a59b-4d5dd8eb2eb45
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY7b4c7e4c-1536-45ab-a59b-4d5dd8eb2eb45
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY7b4c7e4c-1536-45ab-a59b-4d5dd8eb2eb45
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY7b4c7e4c-1536-45ab-a59b-4d5dd8eb2eb45
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY7b4c7e4c-1536-45ab-a59b-4d5dd8eb2eb45
307668APAP 32 MG/ML Oral SuspensionSY7b4c7e4c-1536-45ab-a59b-4d5dd8eb2eb45

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0946-10001130946101 BOTTLE in 1 CARTON (0113-0946-10) / 30 mL in 1 BOTTLE1 bottle2011-11-080000-00-00NoNoCurrent