FDA.reportPublic FDA data

Bactimicina Childrens Pain and Fever

Product NDC
24286-1550
11-digit product format
242861550
Labeler code
24286
Product ID
24286-1550_47d53810-ddd8-346c-e063-6394a90a6cd4
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN
Dosage form
LIQUID
Route
ORAL
Labeler
DLC Laboratories, Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-11-17
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
Bactimicina Childrens Pain and 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
307675Internal RxNorm lookup
1038779Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bdade270-d813-4178-b594-4951632b6839Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24286-1550-4Bactimicina Childrens Pain and Fever1 in 1 BOXLIQUID19
24286-1550-4Bactimicina Childrens Pain and Fever118 mL in 1 BOTTLELIQUID1189

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DBACTIMICINA CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) LIQUID [DLC LABORATORIES, INC.]4
ACETAMINOPHENACTIVE MOIETY362O9ITL9DBACTIMICINA CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) LIQUID [DLC LABORATORIES, INC.]4
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPBACTIMICINA CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) LIQUID [DLC LABORATORIES, INC.]4
CORN SYRUPINACTIVE INGREDIENT9G5L16BK6NBACTIMICINA CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) LIQUID [DLC LABORATORIES, INC.]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABACTIMICINA CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) LIQUID [DLC LABORATORIES, INC.]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBACTIMICINA CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) LIQUID [DLC LABORATORIES, INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBACTIMICINA CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) LIQUID [DLC LABORATORIES, INC.]4
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUBACTIMICINA CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) LIQUID [DLC LABORATORIES, INC.]4
SORBITOLINACTIVE INGREDIENT506T60A25RBACTIMICINA CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) LIQUID [DLC LABORATORIES, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RBACTIMICINA CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) LIQUID [DLC LABORATORIES, INC.]4
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEBACTIMICINA CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) LIQUID [DLC LABORATORIES, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24286-1550BACTIMICINA CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) LIQUID [DLC LABORATORIES, INC.]8Current NDC, Legacy NDC, 2 package rows20241012_bdade270-d813-4178-b594-4951632b6839.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 67 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain Relief Extra StrengthACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION, INC.9fdbaf5e-f88b-4d18-97df-0b2e8dddf3772024-06-13WarningsExact identifier
application number: M013
Aspirin 81 mg Low doseASPIRINCHAIN DRUG MARKETING ASSOCIATION, INC.bfb9af64-3195-44bf-bcf3-6b36b40d3cc72024-06-13WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION, INC.1ac7ed71-5afe-d09c-e063-6294a90a3b882024-06-13WarningsExact identifier
application number: M013
Pain Relief PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.3ce5bbf2-d449-464e-abeb-5c26866d1ab52024-06-13WarningsExact identifier
application number: M013
AspirinASPIRINAAA Pharmaceutical, Inc.609948d6-0f20-4d0c-adc0-6ae72a4f2b7a2024-06-13WarningsExact identifier
application number: M013
AspirinASPIRINAAA Pharmaceutical, Inc.3f73a359-59d7-47bb-872e-914b0db719af2024-06-13WarningsExact identifier
application number: M013
topcare infants pain and feverACETAMINOPHENTopco Associates LLCf1e940ef-3cf0-4a5c-8158-156d0e5a680d2024-06-13WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENTrifecta Pharmaceuticals USA LLC026bf664-d598-73de-e063-6394a90a92062024-06-12WarningsExact identifier
application number: M013
Regular Strength Pain ReliefACETAMINOPHENNuCare Pharmaceuticals,Inc.7c73fc75-af9b-177c-e053-2a91aa0ada562024-06-12WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINTopco Associates4a6a1dbb-c813-42fd-9bb8-497aec3394662024-06-11WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEThe Kroger Co.fa234639-caf8-4c52-9ffe-f1c0c057ee5b2024-06-10WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEThe Kroger Co.bc18590d-6481-4efe-8a3b-974f7543b7542024-06-10WarningsExact identifier
application number: M013
ASPIRINASPIRINH-E-B085b35db-62e4-38db-e063-6394a90a97632024-06-07WarningsExact identifier
application number: M013
pain and feverACETAMINOPHENMeijer Distribution Inccbfa2a25-f1e7-491e-9b67-ff2f4ba0b6cf2024-06-07WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEThe Kroger Co.5691ac45-5732-412e-abb8-2bfaac59160e2024-06-07WarningsExact identifier
application number: M013
Cafiaspirina Rapid Headache ReliefASPIRIN, CAFFEINEBelmora LLCd890acec-6528-4fb7-8d59-6c572a3f07862024-06-07WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINETARGET Corporation611bc1ce-460a-44a3-8e2d-b28a399d9a442024-06-06WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENMeijer Distribution Inc033a6153-2651-4703-8a94-def4618381132024-06-05WarningsExact identifier
application number: M013
CareOne Childrens AcetaminophenACETAMINOPHENAmerican Sales Company126ee71a-c408-415b-9a43-502337a910552024-06-05WarningsExact identifier
application number: M013
Tylenol Extra StrengthACETAMINOPHENA-S Medication Solutions85294a70-3233-4ba5-bc36-ee3f2964aebf2024-06-05WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307675acetaminophen 160 MG in 5 mL Oral SolutionPSNbdade270-d813-4178-b594-4951632b68399
1038779BACTIMICINA Children's Pain & Fever 160 MG in 5 mL Oral SolutionPSNbdade270-d813-4178-b594-4951632b68399
1038779acetaminophen 32 MG/ML Oral Solution [Bactimicina]SBDbdade270-d813-4178-b594-4951632b68399
307675acetaminophen 32 MG/ML Oral SolutionSCDbdade270-d813-4178-b594-4951632b68399
307675acetaminophen 160 MG per 5 ML Oral SolutionSYbdade270-d813-4178-b594-4951632b68399
307675acetaminophen 325 MG per 10.15 ML Oral SolutionSYbdade270-d813-4178-b594-4951632b68399
307675acetaminophen 650 MG per 20.3 ML Oral SolutionSYbdade270-d813-4178-b594-4951632b68399
307675acetaminophen 80 MG per 2.5 ML Oral SolutionSYbdade270-d813-4178-b594-4951632b68399
307675APAP 32 MG/ML Oral SolutionSYbdade270-d813-4178-b594-4951632b68399
1038779APAP 32 MG/ML Oral Solution [Bactimicina]SYbdade270-d813-4178-b594-4951632b68399
1038779Bactimicina 160 MG per 5 ML Oral SolutionSYbdade270-d813-4178-b594-4951632b68399
1038779Bactimicina 32 MG/ML Oral SolutionSYbdade270-d813-4178-b594-4951632b68399

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24286-1550-4242861550041 BOTTLE in 1 BOX (24286-1550-4) / 118 mL in 1 BOTTLE1 bottle2014-11-170000-00-00NoNoCurrent