FDA.reportPublic FDA data

infants fever reducer and pain reliever

Product NDC
11822-0590
11-digit product format
118220590
Labeler code
11822
Product ID
11822-0590_99336d7f-3762-401c-a834-ac455f285469
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Rite Aid Corporation
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1993-09-08
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
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
infants fever reducer and pain reliever
Listing expiration
2027-12-31

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
baee03b8-fcfd-440e-90ea-1ee2a18516efAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11822-0590-12023-11-07C16284748780-1f386c649-bce3-0266-e053-dadaa90a7c1aRite Aid Corporation Infants’ Fever Reducer & Pain Reliever Drug Facts
11822-0590-12023-01-30C16284748780-1f386c649-bce3-0266-e053-dadaa90a7c1aRite Aid Corporation Infants’ Fever Reducer & Pain Reliever Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-0590-1infants fever reducer and pain reliever59 mL in 1 BOTTLESUSPENSION597
11822-0590-1infants fever reducer and pain reliever1 in 1 CARTONSUSPENSION17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DINFANTS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DINFANTS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLINFANTS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION]3
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505INFANTS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION]3
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311INFANTS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION]3
CARRAGEENANINACTIVE INGREDIENT5C69YCD2YJINFANTS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UINFANTS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXINFANTS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3INFANTS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION]3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHINFANTS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUINFANTS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION]3
SODIUM PHOSPHATE, TRIBASICINACTIVE INGREDIENTA752Q30A6XINFANTS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION]3
SORBITOLINACTIVE INGREDIENT506T60A25RINFANTS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION]3
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4INFANTS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION]3
WATERINACTIVE INGREDIENT059QF0KO0RINFANTS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0590INFANTS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION]7Current NDC, Legacy NDC, 2 package rows20241104_baee03b8-fcfd-440e-90ea-1ee2a18516ef.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 8 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AspirinASPIRINUnited Natural Foods, Inc. dba UNFI19c7f832-d7ec-4dcc-8aa4-f4cbf64c9ff62026-07-02WarningsExact identifier
application number: M013
pain relief EXTRA STRENGTHACETAMINOPHENMeijer Distribution, Inc.ae84eb7e-a70b-4311-b2dc-ad153047a5162026-07-01WarningsExact identifier
application number: M013
Aspirin 325 mgASPIRINHi-Tech Nutraceuticals, LLCb3426a9a-ea99-da30-e053-2995a90a1e4b2026-07-01WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINESalado Sales, Inc.ca21d576-be3c-495d-9dbd-ed514bf65da72026-07-01WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENMeijer Distribution Inc4e08a7cb-3894-84c3-e063-6394a90a0b422026-06-30WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINEWal-Mart Stores Inc9b1201af-c802-4e19-b192-bbbf34367db42026-06-30WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENP & L Development, LLCfc841cba-8f4f-407b-97de-0422977515bd2026-06-30WarningsExact identifier
application number: M013
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEUnited Natural Foods, Inc. dba UNFIb6ff2b34-51ee-41bc-8b7d-7520ade0bf362026-06-30WarningsExact identifier
application number: M013
MedlineASPIRINMedline Industries, LP4b0c569a-ed7a-e104-e063-6394a90a6d542026-06-29WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLWALMART INC.e50b3f60-b827-426c-8e78-8447c89130fe2026-06-29WarningsExact identifier
application number: M013
Acetaminophen PMACETAMINOPHEN, DIPHENHYDRAMINE HCLChain Drug Marketing Association, Inc.e58417f4-3575-4433-ac2e-b7bf9fe8ba102026-06-29WarningsExact identifier
application number: M013
Dr Kids Pain and FeverACETAMINOPHENCalmCo LLC5534a784-a7b1-5599-e063-6294a90a79612026-06-27WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENSelect Consumer Group LLC529d3a51-a248-7c02-e063-6294a90a10ae2026-06-27WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENSportpharm LLC830ffcaa-7ff8-4732-bc84-6a8c5e78722d2026-06-25WarningsExact identifier
application number: M013
AspirinASPIRINStrategic Sourcing Services LLCea2ef485-429e-4c63-ba7b-0a6b32892ad22026-06-25WarningsExact identifier
application number: M013
AspirinASPIRINChain Drug Marketing Association, Inc.055d8420-c189-4a9e-acdc-21627935c8eb2026-06-25WarningsExact identifier
application number: M013
AspirinASPIRINTopco Associates, LLC5f32cf74-dbea-496c-ba23-2040ea354f402026-06-25WarningsExact identifier
application number: M013
AspirinASPIRINSalado Sales, Inc.cf3139a5-e36e-48e3-bb6c-e102b0cec5552026-06-25WarningsExact identifier
application number: M013
Pain Relief AspirinASPIRINRite Aid Corporationbd69d3d2-5d38-47c6-98a6-124f7a43b8b02026-06-25WarningsExact identifier
application number: M013
Aspirin Regular StrengthASPIRINWalgreen Company0b27c0fd-7ea8-4588-9169-5ad4e8df77ef2026-06-25WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSNbaee03b8-fcfd-440e-90ea-1ee2a18516ef7
307668acetaminophen 32 MG/ML Oral SuspensionSCDbaee03b8-fcfd-440e-90ea-1ee2a18516ef7
307668acetaminophen 160 MG per 5 ML Oral SuspensionSYbaee03b8-fcfd-440e-90ea-1ee2a18516ef7
307668acetaminophen 320 MG per 10 ML Oral SuspensionSYbaee03b8-fcfd-440e-90ea-1ee2a18516ef7
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSYbaee03b8-fcfd-440e-90ea-1ee2a18516ef7
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSYbaee03b8-fcfd-440e-90ea-1ee2a18516ef7
307668APAP 32 MG/ML Oral SuspensionSYbaee03b8-fcfd-440e-90ea-1ee2a18516ef7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0590-1118220590011 BOTTLE in 1 CARTON (11822-0590-1) / 59 mL in 1 BOTTLE1 bottle1993-09-080000-00-00NoNoCurrent