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 45 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain ReliefACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION, INC.1c083e29-8732-4ecd-ab4b-9038acbd0b9d2025-05-22WarningsExact identifier
application number: M013
TYLENOL For Children Plus AdultsACETAMINOPHENKenvue Brands LLC5bb8ef99-a94b-49f9-89f9-cd1ce0a47a422025-05-21WarningsExact identifier
application number: M013
Children AcetaminophenACETAMINOPHENAARNA USA INC.25bcb9d5-f388-4ae7-8037-970ffe8d17f02025-05-16WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENHF Acquisition Co LLC, DBA HealthFirst35478de8-50d0-5d0a-e063-6294a90a88ba2025-05-16WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENPreferred Pharmaceuticals Inc.95f4b628-6d35-4f6b-91f9-b2d117f8e8212025-05-16WarningsExact identifier
application number: M013
good neighbor pharmacy childrens pain and feverACETAMINOPHENAmerisource Bergen268a789b-8f31-4739-9777-523249cac3262025-05-13WarningsExact identifier
application number: M013
ASPIRIN LOW DOSEASPIRIN LOW DOSEAARNA USA INC.347edc8f-6391-b75e-e063-6394a90a1cf52025-05-06WarningsExact identifier
application number: M013
Good Neighbor Pharmacy Infants Pain and FeverACETAMINOPHENAmerisource Bergen2cfbb8ad-3ecb-432b-9eb4-16c51bf23bb22025-05-06WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENAARNA USA INC.34157f6a-3031-4388-e063-6394a90a670f2025-05-01WarningsExact identifier
application number: M013
ASPIRINASPIRINHF Acquisition Co LLC, DBA HealthFirst2553d0cb-3f5c-7ea0-e063-6294a90a3cd42025-05-01Warnings, Adverse reactionsExact identifier
application number: M013
Aspirin 81mg Enteric CoatedASPIRINAdvanced Rx LLC606067bb-b07f-444e-9465-d1e187735f3a2025-05-01WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENAARNA USA INC.33f0e822-28af-9bb2-e063-6294a90a51752025-04-29WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENGeri-Care Pharmaceutical Corp27fcca07-f845-77fe-e063-6394a90aa2f82025-04-24WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENA-S Medication Solutions46a6bbb9-ccd1-47a8-9e58-485f71f570632025-04-24WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENA-S Medication Solutions061c91d5-5aa8-4556-a344-197b7e8a10b82025-04-24WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENA-S Medication Solutionsc4f0f591-8501-4c6d-bf8e-ca3068ff65b52025-04-24WarningsExact identifier
application number: M013
Extra Strength No-PainACETAMINOPHENSafrel Pharmaceuticals, LLC.873f01dd-0701-5fd3-e053-2a95a90a64632025-04-23WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENChain Drug Consortium60d4b392-6ed0-4115-8154-24eaf72504a52025-04-16WarningsExact identifier
application number: M013
Premsyn pms Premenstrual Pain ReliefACETAMINOPHEN AND PAMABROM AND PYRILAMINE MALEATEFocus Consumer Healthcare, LLC5b6f6260-69ae-cfeb-e053-2a91aa0a6b492025-04-14WarningsExact identifier
application number: M013
BackAid MaxACETAMINOPHEN, PAMABROMKobayashi Healthcare International, Inc.fb9a5647-b7c9-4820-b148-91060e34cb832025-04-14WarningsExact 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