FDA.reportPublic FDA data

Childrens Pain and Fever Cherry flavor

Product NDC
0363-0322
11-digit product format
003630322
Labeler code
0363
Product ID
0363-0322_61af0cb4-d328-4256-8516-2cc5781dcbd5
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN
Dosage form
SUSPENSION
Route
ORAL
Labeler
Walgreen Company
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-11-05
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
Childrens Pain and Fever Cherry flavor
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
64c65244-f7a3-401b-b83a-bf66d45268e2Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0322-24Childrens Pain and Fever Cherry flavor1 in 1 CARTONSUSPENSION12
0363-0322-24Childrens Pain and Fever Cherry flavor118 mL in 1 BOTTLESUSPENSION1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0322CHILDRENS PAIN AND FEVER CHERRY FLAVOR (ACETAMINOPHEN) SUSPENSION [WALGREEN COMPANY]2Current NDC, Legacy NDC, 2 package rows20231230_64c65244-f7a3-401b-b83a-bf66d45268e2.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 60 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Enteric Coated AspirinASPIRINSTRATEGIC SOURCING SERVICES LLC32cc6e05-84c1-4710-bebc-cb6e7133dc542024-10-17WarningsExact identifier
application number: M013
AspirinASPIRINSTRATEGIC SOURCING SERVICES LLC2ca87a29-1f54-4da4-a66f-3b3dd4f0396c2024-10-17WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENSTRATEGIC SOURCING SERVICES LLC9f0aef5d-20b0-469d-a58d-1cbf83a0dd8e2024-10-17WarningsExact identifier
application number: M013
AspirinASPIRINKroger Company453f62d5-f580-4d19-bfae-4f78c2a6b6d62024-10-16WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENFSA Store Inc.ec6add55-f4a3-7818-e053-2a95a90aee042024-10-16WarningsExact identifier
application number: M013
ASPIRINASPIRINFSA Store Inc.062e7b7b-d052-82b0-e063-6294a90a7cce2024-10-16WarningsExact identifier
application number: M013
Acetaminophen PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEFSA STORE INC.f4322f34-ac19-371e-e053-2a95a90ac8642024-10-16WarningsExact identifier
application number: M013
Low dose Chewable AspirinASPIRINFSA STORE INC.f939b44c-93b6-ca61-e053-6394a90ae5862024-10-16WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENDISCOUNT DRUG MART850b5ad8-8774-413c-ae38-022215a94f952024-10-16WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINDISCOUNT DRUG MARTaf0f50d2-3e2d-f723-e053-2995a90a0d4b2024-10-16WarningsExact identifier
application number: M013
Enteric Coated AspirinASPIRINDISCOUNT DRUG MART03ed19dd-1cfc-47d5-b83e-ffa2ebe93f482024-10-16WarningsExact identifier
application number: M013
PAIN RELIEF Regular StrengthACETAMINOPHENAMERICAN SALES COMPANY2e3eabc8-193b-4397-a43c-db838eb16e672024-10-15WarningsExact identifier
application number: M013
Chewable AspirinASPIRINRETAIL BUSINESS SERVICES , LLC.c94d68ea-7f25-881f-e053-2995a90aa47f2024-10-15WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINRETAIL BUSINESS SERVICES , LLC.c94d750e-5a85-77f5-e053-2995a90a69152024-10-15WarningsExact identifier
application number: M013
Infants Pain and FeverACETAMINOPHENWalgreen Company9e08eb38-7538-4fa0-a0e1-047ab6cb16802024-10-15WarningsExact identifier
application number: M013
pain reliefACETAMINOPHENPUBLIX SUPER MARKETS INC9e779cc6-4641-6132-e053-2a95a90a34932024-10-11WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENCHAIN DRUG CONSORTIUM5c1a3081-ae25-4895-bf76-ebcbb9fc80722024-10-11WarningsExact identifier
application number: M013
Aspirin 81 MGASPIRINMeijerb3e5711c-9529-4eec-871d-de8efa858b862024-10-11WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENMEIJER DISTRIBUTION INC9586e830-a285-4a07-8b34-9698754423482024-10-11WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENChain Drug Marketing Association68a52858-35c5-402a-8ceb-8d8a7c1e5f6c2024-10-11WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN64c65244-f7a3-401b-b83a-bf66d45268e22
307668acetaminophen 32 MG/ML Oral SuspensionSCD64c65244-f7a3-401b-b83a-bf66d45268e22
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY64c65244-f7a3-401b-b83a-bf66d45268e22
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY64c65244-f7a3-401b-b83a-bf66d45268e22
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY64c65244-f7a3-401b-b83a-bf66d45268e22
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY64c65244-f7a3-401b-b83a-bf66d45268e22
307668APAP 32 MG/ML Oral SuspensionSY64c65244-f7a3-401b-b83a-bf66d45268e22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0322-24003630322241 BOTTLE in 1 CARTON (0363-0322-24) / 118 mL in 1 BOTTLE1 bottle2020-11-050000-00-00NoNoCurrent