FDA.reportPublic FDA data

Childrens Pain and Fever

Product NDC
51316-098
11-digit product format
513160098
Labeler code
51316
Product ID
51316-098_dc7442bd-8264-4b7a-a069-5c2d28e68e90
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-04-05
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
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
d96a1531-772b-4a5c-89e4-66fff1fa3d78Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-098-19Childrens Pain and Fever1 in 1 CARTONSUSPENSION16
51316-098-19Childrens Pain and Fever237 mL in 1 BOTTLE, PLASTICSUSPENSION2376
51316-098-36Childrens Pain and Fever1 in 1 CARTONSUSPENSION16
51316-098-36Childrens Pain and Fever118 mL in 1 BOTTLE, PLASTICSUSPENSION1186

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-098CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED]4Current NDC, 4 package rows20240829_d96a1531-772b-4a5c-89e4-66fff1fa3d78.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 74 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NIGHT-TIME MULTI-SYMPTOM COLD/FLU OriginalACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEDeMoulas Market Basketeb24323f-82a1-4ba3-9359-fe81571c3fba2023-12-29WarningsExact identifier
application number: M013
Nite-TimeCOLD/FLU CHERRY COLD/FLU CHERRYACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATESalado Sales, Inc.e6c3e545-b2ad-47f0-8318-c134a8e24f5b2023-12-29WarningsExact identifier
application number: M013
Daytime Non-Drowsy COLD/FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDESalado Sales, Inc.e181b371-78c7-4163-865d-acc064be33ca2023-12-29WarningsExact identifier
application number: M013
Childrens Pain and Fever Cherry flavorACETAMINOPHENWalgreen Company64c65244-f7a3-401b-b83a-bf66d45268e22023-12-29WarningsExact identifier
application number: M013
Nite-Time COLD/FLU ORIGINALACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATESalado Sales, Inc.fcd24753-b42b-4d05-8379-0ec0351ab2172023-12-29WarningsExact identifier
application number: M013
NIGHT-TIME MULTI-SYMPTOM COLD/FLU CherryACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEDeMoulas Market Baskete772cdf5-d01d-4752-8cfb-7e7f4d7a8dd02023-12-29WarningsExact identifier
application number: M013
Childrens Pain and Fever, Grape flavorACETAMINOPHENWalgreen Company0995d69f-61aa-40b0-b095-bb8595caf7732023-12-29WarningsExact identifier
application number: M013
DAY-TIME Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEDeMoulas Market Basketce900e42-d0c8-408d-a1c3-3a9bef1c97ee2023-12-29WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINE HCLDOLGENCORP, INC.06553550-5685-f3c3-e063-6394a90aef072023-12-22WarningsExact identifier
application number: M013
Tension Headache Pain Relieving AidACETAMINOPHEN,CAFFEINEWAL-MART STORES INC00fadd26-a6eb-dc5e-e063-6394a90a3cca2023-12-15WarningsExact identifier
application number: M013
Dye-Free Aspirin 81ASPIRINWALGREENSd71a9d3a-cd28-14a8-e053-2995a90a832b2023-12-15WarningsExact identifier
application number: M013
Lil Drug Store Aspirin 325ASPIRINLil Drug Store Products, Incde59aae2-f794-4243-acc8-37a10e27abde2023-12-15WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHEN TABLET, EXTRA STRENGTHLil' Drug Store Products, Inc.f0fdab5a-9d07-57aa-e053-2a95a90adc7f2023-12-15WarningsExact identifier
application number: M013
BC CherryASPIRIN AND CAFFEINELil' Drug Store Products, Inc79ea721b-d656-44f7-9d13-390debee7be02023-12-15WarningsExact identifier
application number: M013
Alka-SeltzerBUFFERED ASPIRINLil' Drug Store Products, Inc.0c7a60e7-0bde-9aa2-e063-6294a90a32092023-12-14WarningsExact identifier
application number: M013
Circle K Aspirin 325ASPIRINLil Drug Store Products, Inc4cd306e3-2119-4272-9da4-a848fe2746fa2023-12-14WarningsExact identifier
application number: M013
Circle K Pain Reliever Extra StrengthACETAMINOPHENLil' Drug Store Products, Inc.f2359bc3-901f-4ecb-b402-cb2fe404a9352023-12-14WarningsExact identifier
application number: M013
Childrens Pain ReliefACETAMINOPHENDISCOUNT DRUG MARTc55b8f9d-1396-43c0-acc9-5e3485eadb072023-12-08WarningsExact identifier
application number: M013
Childrens Pain ReliefACETAMINOPHENDISCOUNT DRUG MART775519ad-5683-451f-9bfc-5fafc70c68ec2023-12-08WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENWALGREEN CO.c20c814b-35f5-4c46-e053-2a95a90a50f22023-12-08WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSNd96a1531-772b-4a5c-89e4-66fff1fa3d786
307668acetaminophen 32 MG/ML Oral SuspensionSCDd96a1531-772b-4a5c-89e4-66fff1fa3d786
307668acetaminophen 160 MG per 5 ML Oral SuspensionSYd96a1531-772b-4a5c-89e4-66fff1fa3d786
307668acetaminophen 320 MG per 10 ML Oral SuspensionSYd96a1531-772b-4a5c-89e4-66fff1fa3d786
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSYd96a1531-772b-4a5c-89e4-66fff1fa3d786
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSYd96a1531-772b-4a5c-89e4-66fff1fa3d786
307668APAP 32 MG/ML Oral SuspensionSYd96a1531-772b-4a5c-89e4-66fff1fa3d786

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51316-098-19513160098191 BOTTLE, PLASTIC in 1 CARTON (51316-098-19) / 237 mL in 1 BOTTLE, PLASTIC2024-04-05NoNoCurrent
51316-098-36513160098361 BOTTLE, PLASTIC in 1 CARTON (51316-098-36) / 118 mL in 1 BOTTLE, PLASTIC2024-04-05NoNoCurrent