FDA.reportPublic FDA data

infants fever reducer and pain reliever

Product NDC
11822-0766
11-digit product format
118220766
Labeler code
11822
Product ID
11822-0766_ee050134-cf12-4904-92e2-b3f5bfbdd39f
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
2011-12-07
Marketing end
2026-12-31
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
NDC exclude flag
No
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage11822-076611822-0766-2DDiscontinued by firm2026-10-21

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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

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
920e7055-7ed1-4db4-9215-f8933078bb7bAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
11822-0766-12023-11-16Rite Aid Corporation Infants’ Fever Reducer & Pain Reliever Drug Facts
11822-0766-12023-11-16Rite Aid Corporation Infants’ Fever Reducer & Pain Reliever Drug Facts
11822-0766-22023-11-16Rite Aid Corporation Infants’ Fever Reducer & Pain Reliever Drug Facts
11822-0766-22023-11-16Rite Aid Corporation Infants’ Fever Reducer & Pain Reliever Drug Facts
11822-0766-12023-01-30Rite Aid Corporation Infants’ Fever Reducer & Pain Reliever Drug Facts
11822-0766-12023-01-30Rite Aid Corporation Infants’ Fever Reducer & Pain Reliever Drug Facts
11822-0766-22023-01-30Rite Aid Corporation Infants’ Fever Reducer & Pain Reliever Drug Facts
11822-0766-22023-01-30Rite Aid Corporation Infants’ Fever Reducer & Pain Reliever Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-0766-1infants fever reducer and pain reliever59 mL in 1 BOTTLESUSPENSION5910
11822-0766-1infants fever reducer and pain reliever1 in 1 CARTONSUSPENSION110
11822-0766-2infants fever reducer and pain reliever1 in 1 CARTONSUSPENSION110
11822-0766-2infants fever reducer and pain reliever118 mL in 1 BOTTLESUSPENSION11810

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
11822-0766INFANTS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION]10Current NDC, Legacy NDC, 4 package rows20241102_920e7055-7ed1-4db4-9215-f8933078bb7b.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 47 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain ReliefACETAMINOPHENDISCOUNT DRUG MART97f78c4a-9d0d-4fe1-8b2b-d5f8ab939ac42025-03-07WarningsExact identifier
application number: M013
Redicare Non-Aspirin 500mgREDICARE NON-ASPIRIN, ACETAMINOPHEN 500MGRedicare LLC2f229898-1777-732c-e063-6394a90a76bc2025-03-04Warnings, Adverse reactionsExact identifier
application number: M013
Major Extra Strength Acetaminophen LiquidACETAMINOPHENMajor Pharmaceuticals2f3af4dd-45d5-87b4-e063-6294a90ab3cc2025-02-28WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINNCS HealthCare of KY, LLC dba Vangard Labsed9a71d6-a56e-416a-bb89-6d41307efc5a2025-02-27WarningsExact identifier
application number: M013
AspirinASPIRINPD-Rx Pharmaceuticals, Inc.77429b7f-78e4-42c0-8679-ae8da17488482025-02-26WarningsExact identifier
application number: M013
AeroTab Non-AspirinACETAMINOPHEN 500MG ESAero Healthcarefaa3a4ef-3c70-06ca-e053-6394a90a512d2025-02-26WarningsExact identifier
application number: M013
Bufferin Regular Strength Pain ReliefASPIRINGenomma Lab USA3543b2bf-1062-468a-a5dc-eabb2408af8c2025-02-25WarningsExact identifier
application number: M013
Calmour Childrens Acetaminophen Strips ChewableACETAMINOPHEN ORAL CHEWABLE 80 MGCalmourae47b027-4f29-45bb-a8bd-8129789328352025-02-22WarningsExact identifier
application number: M013
Infants TYLENOLACETAMINOPHENKenvue Brands LLCf9de7c2f-016b-4f40-8b5e-141ad194be972025-02-20WarningsExact identifier
application number: M013
Genexa Acetaminophen PM Extra StrengthACETAMINOPHENGenexa Inc.d82cf6f3-a291-ca2b-e053-2a95a90a6de12025-02-20WarningsExact identifier
application number: M013
Childrens AcetaminophenACETAMINOPHENAdvagen Pharma Limited8b9456c9-a56b-4748-adb8-c66d6bf072e82025-02-19WarningsExact identifier
application number: M013
Genexa Childrens AcetaminophenACETAMINOPHENGenexa Inc.d89fd9d8-d88e-3968-e053-2a95a90afc5f2025-02-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPrecision Dose, Inc.debfa787-7a48-48b5-94b0-6128205240322025-02-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPrecision Dose, Inc.b16e5dcf-b290-4ff2-a150-4b875647ec9a2025-02-19WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLCbb6533e5-e6a9-488c-b8ab-a6a06e87ede92025-02-18WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLCc830320e-72ba-48ff-a4cd-250ac5650bf02025-02-18WarningsExact identifier
application number: M013
Aspirina CapletsASPIRINBayer HealthCare LLC.2e6f5ba8-8e8b-6059-e063-6394a90adcd52025-02-18WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPD-Rx Pharmaceuticals, Inc.da7d95af-6583-429d-8d04-e0424f32e9ad2025-02-17WarningsExact identifier
application number: M013
GOODYS Mental AlertASPIRIN AND CAFFEINEMedtech Products Inc.31ef6d07-d314-4d09-abcd-389ba66cbcc52025-02-17WarningsExact identifier
application number: M013
Aspirin 81 mgASPIRINAsclemed USA, Inc.878dab20-668b-4d7a-a5f8-794a587564d52025-02-13WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN920e7055-7ed1-4db4-9215-f8933078bb7b10
307668acetaminophen 32 MG/ML Oral SuspensionSCD920e7055-7ed1-4db4-9215-f8933078bb7b10
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY920e7055-7ed1-4db4-9215-f8933078bb7b10
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY920e7055-7ed1-4db4-9215-f8933078bb7b10
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY920e7055-7ed1-4db4-9215-f8933078bb7b10
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY920e7055-7ed1-4db4-9215-f8933078bb7b10
307668APAP 32 MG/ML Oral SuspensionSY920e7055-7ed1-4db4-9215-f8933078bb7b10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0766-1118220766011 BOTTLE in 1 CARTON (11822-0766-1) / 59 mL in 1 BOTTLE1 bottle2011-12-072026-12-31NoNoCurrent
11822-0766-2118220766021 BOTTLE in 1 CARTON (11822-0766-2) > 118 mL in 1 BOTTLE1 bottle2017-04-290000-00-00NoNoCurrent