FDA.reportPublic FDA data

Calmour Childrens Acetaminophen Strips

Product NDC
82918-006
11-digit product format
829180006
Labeler code
82918
Product ID
82918-006_2a5a0639-c514-472f-89ac-6baf8ae2f5f0
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen Oral Chewable 80 mg
Dosage form
STRIP
Route
ORAL
Labeler
Calmour
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-25
Substance
ACETAMINOPHEN
Active strength
80 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
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
Calmour Childrens Acetaminophen Strips
Brand name suffix
Chewable
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN80 mg/1

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
2705808Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ae47b027-4f29-45bb-a8bd-812978932835Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82918-006-01Calmour Childrens Acetaminophen StripsChewable1 in 1 POUCHSTRIP11
82918-006-24Calmour Childrens Acetaminophen StripsChewable24 in 1 CARTONSTRIP241
82918-006-36Calmour Childrens Acetaminophen StripsChewable36 in 1 CARTONSTRIP361

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82918-006CALMOUR CHILDRENS ACETAMINOPHEN STRIPS CHEWABLE (ACETAMINOPHEN ORAL CHEWABLE 80 MG) STRIP [CALMOUR]1Current NDC, 3 package rows20250228_ae47b027-4f29-45bb-a8bd-812978932835.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 29 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Regular Strength Pain ReliefACETAMINOPHENVALU MERCHANDISERS COMPANYf7e87eac-59fb-4a72-b5c6-02953112be6a2025-12-11WarningsExact identifier
application number: M013
AspirinASPIRINVALU MERCHANDISERS COMPANY049ec1aa-66b3-9273-e063-6294a90a221b2025-12-11WarningsExact identifier
application number: M013
Aspirin 325ASPIRINWalgreen Companyf7a5d612-443c-4701-ad3b-8eb53c87bece2025-12-11WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPAI Holdings, LLC dba PAI Pharma355a094c-bed9-4959-8cf0-619f0e2461052025-12-11WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPAI Holdings, LLC dba PAI Pharmafac4e0c6-684f-45a1-99f2-de4de4017cc82025-12-11WarningsExact identifier
application number: M013
Pain Reliever PM extra strengthACETAMINOPHEN DIPHENHYDRAMINE HCLP & L Development, LLC90eba2e8-52c3-43f5-ba93-4a520368c7f42025-12-11WarningsExact identifier
application number: M013
Midol Complete, Travel BASIXACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATELil' Drug Store Products, Incd6d47af8-5f8c-4c8c-a8c6-aa214ec23bca2025-12-10WarningsExact identifier
application number: M013
Tylenol PM Extra Strength, CVP HEALTHACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDELil' Drug Store Products, Inc.643371f2-e330-441e-8932-b3aec4b179d22025-12-10WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINUnited Natural Foods, Inc. dba UNFI18b79449-5c4c-41ce-9609-80f5efa0375c2025-12-09WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENAAA Pharmaceutical, Inc.36ad34f4-4e66-f371-e063-6394a90ae76a2025-12-09WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENLIDL US LLCec543339-20ab-2cba-e053-2995a90ac7402025-12-09WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION, INC.c57c10fc-f182-4153-8974-ef359a5f5ac12025-12-09WarningsExact identifier
application number: M013
Pain Relief PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEHEBf7958347-4e9c-4698-8749-7ca7023ee2ba2025-12-09WarningsExact identifier
application number: M013
Pain Relief Rapid Release Gelcaps Extra StrengthACETAMINOPHENSafewayc830d1ac-c4c5-4eb1-98bb-22707cb6db912025-12-09WarningsExact identifier
application number: M013
Menstrual Pain Relief CompleteACETAMINOPHEN, PYRILAMINE MALEATE, CAFFEINEShield Pharmaceuticals Corp5efd6c61-74ed-4253-896a-e4a40bd8f25b2025-12-09WarningsExact identifier
application number: M013
Excedrin Extra Strength, TRAVEL BASIXACETAMINOPHEN, ASPIRIN, AND CAFFEINELil Drug Store Products, Inc7f0f8b3c-c226-4a3a-af46-a708f345e4f52025-12-09WarningsExact identifier
application number: M013
childrens acetaminophenACETAMINOPHENUnited Natural Foods, Inc. dba UNFIf65203a2-64f0-4138-97e4-6eab991941782025-12-09WarningsExact identifier
application number: M013
Pain Reliever PM, Extra Strength, 24-7 Life by 7-ElevenACETAMINOPHEN, DIPHENHYDRAMINE HCL TABLET, FILM COATEDLil' Drug Store Products, Inc.45735cd8-ac07-3f12-e063-6294a90a0cb22025-12-08WarningsExact identifier
application number: M013
BERKLEY AND JENSEN RAPID RELEASE ACETAMINOPHENACETAMINOPHENBJWCe27b6637-ef32-44b5-a531-b6617d02fbbf2025-12-08WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWALGREENS3f9f1740-9e8b-6a2d-e063-6294a90a67cb2025-12-06WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2705808acetaminophen 80 MG Oral FilmPSNae47b027-4f29-45bb-a8bd-8129789328351
2705808acetaminophen 80 MG Oral FilmSCDae47b027-4f29-45bb-a8bd-8129789328351
2705808acetaminophen 80 MG Oral StripSYae47b027-4f29-45bb-a8bd-8129789328351
2705808APAP 80 MG Oral FilmSYae47b027-4f29-45bb-a8bd-8129789328351

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82918-006-01829180006011 in 1 POUCHHistorical
82918-006-248291800062424 POUCH in 1 CARTON (82918-006-24) / 1 STRIP in 1 POUCH (82918-006-01) 24 pouch2025-02-25NoNoCurrent
82918-006-368291800063636 POUCH in 1 CARTON (82918-006-36) / 1 STRIP in 1 POUCH (82918-006-01) 36 pouch2025-03-01NoNoCurrent