Childrens Pain Reliever

Product NDC
68391-288
11-digit product format
683910288
Labeler code
68391
Product ID
68391-288_d65d6677-36da-421d-bb29-0791a28681ac
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
BJWC (Berkley & Jensen / BJ's)
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-08-30
Marketing end
2027-01-29
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
NDC exclude flag
No
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 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
851228ea-eaf3-452b-a9ce-8cd244a0eaf3Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68391-288-12Childrens Pain Reliever118 mL in 1 BOTTLE, PLASTICSUSPENSION1184
68391-288-12Childrens Pain Reliever3 in 1 BOXSUSPENSION34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68391-288CHILDRENS PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [BJWC (BERKLEY & JENSEN / BJ'S)]3Current NDC, Legacy NDC, 2 package rows20240224_851228ea-eaf3-452b-a9ce-8cd244a0eaf3.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 43 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Coated AspirinASPIRINL.N.K. International, Inc.e077fe14-62bb-462b-bfa3-8a83c06c22f12025-07-11WarningsExact identifier
application number: M013
EXTRA PAIN RELIEFACETAMINOPHEN, ASPIRIN AND CAFFEINETIME CAP LABS59482917-f80b-4bed-9218-068b35366eb32025-07-11WarningsExact identifier
application number: M013
Up and Up Childrens acetaminophenACETAMINOPHENTarget Corporation25a476a4-9969-49b3-94bf-b076bada4cea2025-07-10WarningsExact identifier
application number: M013
Tylenol Extra Strength CapletACETAMINOPHENJones Healthcare Group - Packaging Services, Incfba711c1-4e69-49b0-8994-97c455aebcb22025-07-09WarningsExact identifier
application number: M013
good sense pain reliefACETAMINOPHENL. Perrigo Companyaf7ae548-38ad-41d5-b1cb-761cd2e386d32025-07-08WarningsExact identifier
application number: M013
topcare pain reliefACETAMINOPHENTopco Associates LLC6aca88df-d3b5-4a60-b23b-1e66dc41ee7b2025-07-08WarningsExact identifier
application number: M013
equate childrens pain and feverACETAMINOPHENWal-Mart Stores Incf15037a5-4e43-4dd6-93b8-b37a1cc22cd62025-07-07WarningsExact identifier
application number: M013
Childrens Acetaminophen Oral Liquid Grape FlavorACETAMINOPHENAARNA USA INC.39347f5d-2d3c-0c23-e063-6294a90a3a462025-07-05WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENMeijer Distribution Incbe841460-98b4-4448-a494-09ff161fd1312025-07-02WarningsExact identifier
application number: M013
Adult Low Dose AspirinASPIRINAdvanced Rx LLCad0d6a5c-eee9-406c-8d7f-1df9b45f53402025-07-02WarningsExact identifier
application number: M013
EXTRA STRENGHT HEADACHE RELIEFACETAMINOPHEN, ASPIRIN, CAFFEINELil' Drug Store Products, Inc.ec04eb5d-96c0-ddb4-e053-2a95a90a4a922025-07-02WarningsExact identifier
application number: M013
Maximum Strength Cough and Chest Congestion and Nighttime Severe Cold and Flu Combo packDEXTROMETHORPHAN HBR, GUAIFENESIN, ACETAMINOPHEN, DOXYLAMINE SUCCINATEGenexa Inc.18835205-a9e3-15c2-e063-6394a90a81072025-07-02WarningsExact identifier
application number: M013
FeverAllACETAMINOPHENSun Pharmaceutical Industries, Inc.8970b91b-5f3c-4764-9e23-25dcb398d0a72025-07-02WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENMeijer Distribution Inc11c9712d-c3b2-49cd-9c2b-0f57190c954e2025-07-02WarningsExact identifier
application number: M013
Aspirin Regular StrengthASPIRINUnited Natural Foods, Inc. dba UNFI979973c1-661a-4384-8b92-fd901ebde5582025-07-01WarningsExact identifier
application number: M013
Pain and Fever ChildrensACETAMINOPHENCVS Pharmacyf6bbce1c-9790-4ca4-847f-579c594ffe0b2025-07-01WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWALGREENS07d2e322-2465-79e5-e063-6294a90a5ea42025-06-30WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENDISCOUNT DRUG MART66c0cf26-357b-4722-9100-3b86d507a8cd2025-06-30WarningsExact identifier
application number: M013
ALLERGYDIPHENHYDRAMINE HYDROCHLORIDEKroger Companybc019c9e-8fac-5fd3-e053-2a95a90a7ccd2025-06-25WarningsExact identifier
application number: M013
ACETAMINOPHEN Extra StrengthACETAMINOPHENTIME CAP LABS INCfd24d0e0-4f36-42d3-9149-2fb9576903052025-06-25WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN851228ea-eaf3-452b-a9ce-8cd244a0eaf34
307668acetaminophen 32 MG/ML Oral SuspensionSCD851228ea-eaf3-452b-a9ce-8cd244a0eaf34
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY851228ea-eaf3-452b-a9ce-8cd244a0eaf34
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY851228ea-eaf3-452b-a9ce-8cd244a0eaf34
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY851228ea-eaf3-452b-a9ce-8cd244a0eaf34
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY851228ea-eaf3-452b-a9ce-8cd244a0eaf34
307668APAP 32 MG/ML Oral SuspensionSY851228ea-eaf3-452b-a9ce-8cd244a0eaf34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68391-288-12683910288123 BOTTLE, PLASTIC in 1 BOX (68391-288-12) / 118 mL in 1 BOTTLE, PLASTIC2019-08-302027-01-29NoNoCurrent