FDA.reportPublic FDA data

Pediacare Childrens Acetaminophen Grape

Product NDC
52412-906
11-digit product format
524120906
Labeler code
52412
Product ID
52412-906_2a812e53-97e7-9d66-e063-6394a90a72a2
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-01-03
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
Pediacare Childrens Acetaminophen Grape
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
596372c7-eca3-4527-8e22-ab0751e2526bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52412-906-01Pediacare Childrens Acetaminophen Grape1 in 1 CARTONSUSPENSION13
52412-906-01Pediacare Childrens Acetaminophen Grape30 mL in 1 BOTTLESUSPENSION303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52412-906PEDIACARE CHILDRENS ACETAMINOPHEN GRAPE (ACETAMINOPHEN) SUSPENSION [RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH]3Current NDC, Legacy NDC, 2 package rows20250101_596372c7-eca3-4527-8e22-ab0751e2526b.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 66 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AspirinASPIRINWildman Business Groupcdbfcf14-8685-40a9-9778-a3b4329dc1ad2024-07-01WarningsExact identifier
application number: M013
Back Pain Relief Extra Strength DoansMAGNESIUM SALICYLATEWildman Business Group2e17664f-a83f-48d1-8b2b-37f41eea65b62024-07-01WarningsExact identifier
application number: M013
Meijer Effervescent Pain ReliefASPIRINMeijer Distribution Inc17553911-e0fc-e355-e063-6394a90af7b82024-06-28WarningsExact identifier
application number: M013
leader childrens pain and feverACETAMINOPHENCardinal Health 110, LLC. dba Leader4fb4f4b2-c238-4933-b874-08def3b34a282024-06-26WarningsExact identifier
application number: M013
good neighbor pharmacy pain and fever childrensACETAMINOPHENAmerisource Bergenca0833ef-837b-47dc-8676-e016af96622c2024-06-26WarningsExact identifier
application number: M013
leader childrens pain and feverACETAMINOPHENCardinal Health 110, LLC. dba Leader4a030c3e-8104-4a0a-98c5-6ab469451f202024-06-26WarningsExact identifier
application number: M013
Childrens AcetaminophenACETAMINOPHENPadagis Israel Pharmaceuticals Ltda426dd82-b2d6-405e-b0af-cfb1310a6e192024-06-26WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWALMART INC. (see also Equate)7d86a03f-74f4-4b24-b6a6-8747acfe905e2024-06-26WarningsExact identifier
application number: M013
leader childrens pain and feverACETAMINOPHENCardinal Health 110, LLC. dba Leader5bcc5da9-7e64-4308-a5be-2f47a8ca774d2024-06-25WarningsExact identifier
application number: M013
Codeine-GuaifenesinCODEINE PHOSPHATE AND GUAIFENESINNuCare Pharmaceuticals,Inc.9e691264-d48a-6b48-e053-2995a90a93522024-06-20WarningsExact identifier
application number: M013
AspirinREGULAR STRENGTH ENTERIC COATED ASPIRINNuCare Pharmceuticals,Inc.a0705f4f-55cb-214a-e053-2995a90aa6802024-06-20WarningsExact identifier
application number: M013
Extra Strength Pain RelieverACETAMINOPHEN 500 MGLil' Drug Store Products, Inc.ee8e0e79-4da4-101f-e053-2a95a90a30a42024-06-19WarningsExact identifier
application number: M013
Extra Strength Headache ReliefACETAMINOPHEN, ASPIRIN, AND CAFFEINELil' Drug Store Products, Inc.b3a06e4b-0b31-4e2a-8dd1-9de85760477b2024-06-19WarningsExact identifier
application number: M013
pain reliefACETAMINOPHENMeijer Distribution Inc43c3fe72-a4ef-48a6-bc22-a644919c0c5c2024-06-17WarningsExact identifier
application number: M013
Aspirin Regular StrengthASPIRINRETAIL BUSINESS SERVICES , LLC.093182a6-3ed8-5a3f-e063-6294a90a354a2024-06-14WarningsExact identifier
application number: M013
ACETAMINOPHEN PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC.093199be-e92a-6f60-e063-6294a90a85332024-06-14WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENRETAIL BUSINESS SERVICES , LLC.09315a3d-bb2d-4f06-e063-6294a90a3bd32024-06-14WarningsExact identifier
application number: M013
Pain Relief Regular StrengthACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION INC613bc633-0426-41a7-aea9-9ff56311b6072024-06-13WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENChain Drug Marketing Associationcfaf9495-e654-4dfc-ba23-d2358c3720c42024-06-13WarningsExact identifier
application number: M013
Aspirin 81 mg Low DoseASPIRINCHAIN DRUG MARKETING ASSOCIATION, INC.18ff2df8-ee65-4219-ad93-cf5090bfac2d2024-06-13WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN596372c7-eca3-4527-8e22-ab0751e2526b3
307668acetaminophen 32 MG/ML Oral SuspensionSCD596372c7-eca3-4527-8e22-ab0751e2526b3
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY596372c7-eca3-4527-8e22-ab0751e2526b3
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY596372c7-eca3-4527-8e22-ab0751e2526b3
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY596372c7-eca3-4527-8e22-ab0751e2526b3
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY596372c7-eca3-4527-8e22-ab0751e2526b3
307668APAP 32 MG/ML Oral SuspensionSY596372c7-eca3-4527-8e22-ab0751e2526b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52412-906-01524120906011 BOTTLE in 1 CARTON (52412-906-01) / 30 mL in 1 BOTTLE1 bottle2023-01-030000-00-00NoNoCurrent