FDA.reportPublic FDA data

ADWE Childrens Pain Fever

Product NDC
68163-695
Requested package NDC
68163-695-04
11-digit product format
681630695
Labeler code
68163
Product ID
68163-695_3a1d9104-d156-2b4e-e063-6394a90a8d05
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
RARITAN PHARMACEUTICALS INC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-01-17
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ADWE Childrens Pain 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
79a3232f-0211-4c8a-acee-4f87e06ffc26Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68163-695-04ADWE Childrens Pain Fever120 mL in 1 BOTTLE, PLASTICSUSPENSION1205
68163-695-04ADWE Childrens Pain Fever1 in 1 PACKAGESUSPENSION15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68163-695ADWE CHILDRENS PAIN FEVER (ACETAMINOPHEN) SUSPENSION [RARITAN PHARMACEUTICALS INC]4Current NDC, Legacy NDC, 2 package rows20240719_79a3232f-0211-4c8a-acee-4f87e06ffc26.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 1 of 85 · 1,689 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Pain plus Fever ReliefACETAMINOPHENCVS PHARMACYe4cbfb06-d826-4d08-95d6-60305c4176252026-08-14WarningsExact identifier
application number: M013
Childrens Pain ReliefACETAMINOPHENCVS Pharmacy,Inc.3738d35c-1e83-40df-9292-c54e6b2c83532026-08-14WarningsExact identifier
application number: M013
CVS Childrens Pain plus Fever ReliefACETAMINOPHENCVS PHARMACY22a48a33-995b-481e-9e4e-1ad7ec346f442026-08-14WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENTopco Associates, LLC8b9e90da-98e2-4d8d-bf6e-54b0a8f8d1012026-08-12WarningsExact identifier
application number: M013
Aspirin 81mgASPIRINHARRIS TEETER54e69d5a-55d7-4ebe-8494-0be93613f1e22026-08-12WarningsExact identifier
application number: M013
Chewable AspirinASPIRINHARRIS TEETERc6a28c83-60c9-3304-e053-2a95a90aa06c2026-08-12WarningsExact identifier
application number: M013
ASPIRINASPIRINHARRIS TEETER93cbd3cb-1072-89e6-e053-2995a90a2f152026-08-12WarningsExact identifier
application number: M013
Adult Chewable AspirinASPIRINHARRIS TEETERc6a28617-1769-7a7d-e053-2995a90a1ea02026-08-12WarningsExact identifier
application number: M013
Gencare- Pain Relief AcetaminophenACETAMINOPHENPioneer Life Sciences, LLC2111c91b-2fd7-4ab3-946a-d4e0cf46399a2026-08-12WarningsExact identifier
application number: M013
Pain Reliever Extra StrengthACETAMINOPHENSalado Sales, Inc.1dbd8480-5cb4-4577-9091-b2a2add4f1af2026-08-12WarningsExact identifier
application number: M013
pain relief childrensACETAMINOPHENRite Aid Corporation29ecdd2d-aeaf-40a8-a347-011088009ea62026-08-11WarningsExact identifier
application number: M013
Fast Acting Pedia CraeACETAMINOPHENRandob Labs., Ltd.e069060f-fbb2-4c7a-b872-00b3ab86d01b2026-08-11WarningsExact identifier
application number: M013
ASPIRINASPIRINAmazon.com Services LLCc7cc0681-4c0b-4565-99df-d0168c8ba1ba2026-08-10WarningsExact identifier
application number: M013
GenCare Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEPioneer Life Sciences, LLCac8c4bdf-30c9-2b09-e053-2a95a90a9b672026-08-09WarningsExact identifier
application number: M013
Gencare-Aspirin Low Dose Pain reliever (NSAID)ASPIRINPioneer Life Sciences, LLC24d4f46a-c7a5-4e94-804f-1e307d8e8cfc2026-08-09WarningsExact identifier
application number: M013
Aspirin 81 mgASPIRINDOLGENCORP, LLCb4064039-2345-4227-b83d-54dc13a838d32026-08-07WarningsExact identifier
application number: M013
berkley and jensen acetaminophenACETAMINOPHENBJWCdee57d73-73ac-48bb-b1da-9971f1ff21c42026-08-07WarningsExact identifier
application number: M013
AspirinASPIRINP & L Development, LLC4cd74cec-a209-4e92-b853-fbe5c95f76782026-08-06WarningsExact identifier
application number: M013
Tension Headache Aspirin-FreeACETAMINOPHEN, CAFFEINERite Aid Corporation093a7c26-f2b1-4416-b193-81133d247d2e2026-08-06WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENKroger Companybc17b2e5-4828-6a2e-e053-2995a90a8c632026-08-05WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN79a3232f-0211-4c8a-acee-4f87e06ffc265
307668acetaminophen 32 MG/ML Oral SuspensionSCD79a3232f-0211-4c8a-acee-4f87e06ffc265
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY79a3232f-0211-4c8a-acee-4f87e06ffc265
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY79a3232f-0211-4c8a-acee-4f87e06ffc265
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY79a3232f-0211-4c8a-acee-4f87e06ffc265
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY79a3232f-0211-4c8a-acee-4f87e06ffc265
307668APAP 32 MG/ML Oral SuspensionSY79a3232f-0211-4c8a-acee-4f87e06ffc265

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68163-695-04681630695041 BOTTLE, PLASTIC in 1 PACKAGE (68163-695-04) / 120 mL in 1 BOTTLE, PLASTIC2022-01-170000-00-00NoNoCurrent