FDA.reportPublic FDA data

childrens fever reducer and pain reliever

Product NDC
11822-0595
11-digit product format
118220595
Labeler code
11822
Product ID
11822-0595_eb8454b5-d82a-47b3-b1c5-cdb198f2ba63
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
1997-09-23
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
NDC exclude flag
No
Listing certified through
2027-12-31
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 packagepackage11822-059511822-0595-5DDiscontinued by firm2026-10-27

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
childrens 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
f6e51c4b-2941-4862-8262-bd9716324841Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
11822-0595-42023-09-20Rite Aid Corporation Children’s Fever Reducer & Pain Reliever Drug Facts
11822-0595-52023-09-20Rite Aid Corporation Children’s Fever Reducer & Pain Reliever Drug Facts
11822-0595-42023-01-30Rite Aid Corporation Children’s Fever Reducer & Pain Reliever Drug Facts
11822-0595-52023-01-30Rite Aid Corporation Children’s Fever Reducer & Pain Reliever Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-0595-4childrens fever reducer and pain reliever118 mL in 1 BOTTLESUSPENSION1189
11822-0595-4childrens fever reducer and pain reliever1 in 1 CARTONSUSPENSION19
11822-0595-5childrens fever reducer and pain reliever1 in 1 CARTONSUSPENSION19
11822-0595-5childrens fever reducer and pain reliever148 mL in 1 BOTTLESUSPENSION1489

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DCHILDRENS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DCHILDRENS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCHILDRENS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION]3
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8CHILDRENS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION]3
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505CHILDRENS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION]3
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311CHILDRENS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION]3
CARRAGEENANINACTIVE INGREDIENT5C69YCD2YJCHILDRENS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCHILDRENS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION]3
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LCHILDRENS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCHILDRENS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHILDRENS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION]3
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SCHILDRENS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CHILDRENS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCHILDRENS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION]3
SODIUM PHOSPHATE, TRIBASICINACTIVE INGREDIENTA752Q30A6XCHILDRENS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION]3
SORBITOLINACTIVE INGREDIENT506T60A25RCHILDRENS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION]3
WATERINACTIVE INGREDIENT059QF0KO0RCHILDRENS 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
11822-0595CHILDRENS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION]9Current NDC, Legacy NDC, 4 package rows20241004_f6e51c4b-2941-4862-8262-bd9716324841.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 49 of 79 · 1,561 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dye Free Childrens AcetaminophenACETAMINOPHENPrecision Dose Inc.5cc698fa-0841-4851-ae21-0aac8b40eb0a2025-01-16WarningsExact identifier
application number: M013
EcotrinASPIRINMedtech Products Inc.222d187b-aae6-410b-baeb-b2bd42f5c6762025-01-16WarningsExact identifier
application number: M013
Children Pain and Fever RelieverACETAMINOPHENTarget Corporation0dd643a4-3cbc-423d-95b4-ba373b09d8952025-01-16WarningsExact identifier
application number: M013
Chewable Low Dose AspirinASPIRINTARGET CORPORATIONf934e72a-2e9f-da17-e053-6394a90a1a2e2025-01-15WarningsExact identifier
application number: M013
ACETAMINOPHEN 500 MGACETAMINOPHENReliable 1 Laboratories LLC2651bf11-4d66-43ba-e054-00144ff88e882025-01-15WarningsExact identifier
application number: M013
ASPIRIN 325 MG ECASPIRINReliable 1 Laboratories LLC2ab8564f-f958-7512-e054-00144ff88e882025-01-15WarningsExact identifier
application number: M013
ACETAMINOPHEN 325 MGACETAMINOPHENReliable 1 Laboratories LLC25626b46-78f8-7226-e054-00144ff8d46c2025-01-15WarningsExact identifier
application number: M013
Aspirin 81 mgASPIRINReliable 1 Laboratories LLCb247fe39-7f65-e502-e053-2a95a90a08f12025-01-15WarningsExact identifier
application number: M013
PharbetolACETAMINOPHEN 500MGUlai Health LLCe64ce7b1-4501-4b51-b012-1882ed153b422025-01-13WarningsExact identifier
application number: M013
Aspirin Regular StrengthASPIRIN 325MGUlai Health LLC26942d32-d6e6-464d-8fc4-ffd9806d3e622025-01-12WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENWAL-MART STORES INCa354b24e-0913-829f-e053-2995a90ad4072025-01-11WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENWAL-MART STORES INC8f221fdb-8138-c1a8-e053-2995a90a29c22025-01-11WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINA-S Medication Solutions3294ba24-f198-485e-88fc-435964434b802025-01-09WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENMajor Pharmaceuticals32ea1230-f9ae-46b0-910e-05cd187cee342025-01-09WarningsExact identifier
application number: M013
GeriCare Liquid Pain ReliefACETAMINOPHENGeri-Care Pharmaceuticals, Corp85a074da-14b7-4db5-9d47-8ad19f5207212025-01-06WarningsExact identifier
application number: M013
Aspirin 81 mg Low DoseASPIRINMeijer Distribution Inceb29d6be-f095-44b2-b6ed-7e4167b596f82025-01-02WarningsExact identifier
application number: M013
Headache, Circle KACETAMINOPHEN, CAFFEINE, ASPIRIN TABLETLil' Drug Store Products, Inc.e711ff0a-2fa0-1f2a-e053-2a95a90a4e382024-12-31WarningsExact identifier
application number: M013
Extra Strength Headache, Lil Drug StoreEXTRA STRENGHT HEADACHE RELIEF- ACETAMINOPHEN, ASPIRIN, CAFFEINE TABLETLil' Drug Store Products, Inc.0c41deda-490b-f5d2-e063-6394a90a50472024-12-31WarningsExact identifier
application number: M013
Extra Strength Headache, Circle KACETAMINOPHEN/ASPIRIN/CAFFEINE TABLETLil' Drug Store Products, Inc.d18e1631-de43-4b29-e053-2995a90af56d2024-12-31WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHEN 500 MG, FILM-COATED TABLETLil' Drug Store Products, Inc.e5f9def4-4cf5-4e06-e053-2995a90a07ea2024-12-31WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSNf6e51c4b-2941-4862-8262-bd97163248419
307668acetaminophen 32 MG/ML Oral SuspensionSCDf6e51c4b-2941-4862-8262-bd97163248419
307668acetaminophen 160 MG per 5 ML Oral SuspensionSYf6e51c4b-2941-4862-8262-bd97163248419
307668acetaminophen 320 MG per 10 ML Oral SuspensionSYf6e51c4b-2941-4862-8262-bd97163248419
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSYf6e51c4b-2941-4862-8262-bd97163248419
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSYf6e51c4b-2941-4862-8262-bd97163248419
307668APAP 32 MG/ML Oral SuspensionSYf6e51c4b-2941-4862-8262-bd97163248419

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0595-4118220595041 BOTTLE in 1 CARTON (11822-0595-4) / 118 mL in 1 BOTTLE1 bottle1997-09-230000-00-00NoNoCurrent
11822-0595-5118220595051 BOTTLE in 1 CARTON (11822-0595-5) > 148 mL in 1 BOTTLE1 bottle1997-09-230000-00-00NoNoCurrent