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 60 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen Regular StrengthACETAMINOPHENUnited Natural Foods, Inc. dba UNFI1462b308-a6a5-49ca-ab29-cacbf62caf0b2024-10-17WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENUnited Natural Foods, Inc. dba UNFIf3db8598-fe0e-4c53-a023-5f5f8f002cc62024-10-17WarningsExact identifier
application number: M013
acetaminophen pm extra strengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFIf86a11af-6d3c-4638-870d-a663ddf493712024-10-17WarningsExact identifier
application number: M013
Acetaminophen Gelcaps Extra StrengthACETAMINOPHENUnited Natural Foods, Inc. dba UNFI3588a3ef-a493-43ed-96e0-c259f0d087db2024-10-17WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENSTRATEGIC SOURCING SERVICES LLCa2186895-944b-48cb-b3c2-eac208866c342024-10-17WarningsExact identifier
application number: M013
Pain Relief Regular StrengthACETAMINOPHENSTRATEGIC SOURCING SERVICES LLC6a5d43c8-f4b7-4447-b2e1-53eb12208ef02024-10-17WarningsExact identifier
application number: M013
Enteric Coated AspirinASPIRINSTRATEGIC SOURCING SERVICES LLC32cc6e05-84c1-4710-bebc-cb6e7133dc542024-10-17WarningsExact identifier
application number: M013
AspirinASPIRINSTRATEGIC SOURCING SERVICES LLC2ca87a29-1f54-4da4-a66f-3b3dd4f0396c2024-10-17WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENSTRATEGIC SOURCING SERVICES LLC9f0aef5d-20b0-469d-a58d-1cbf83a0dd8e2024-10-17WarningsExact identifier
application number: M013
AspirinASPIRINKroger Company453f62d5-f580-4d19-bfae-4f78c2a6b6d62024-10-16WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENFSA Store Inc.ec6add55-f4a3-7818-e053-2a95a90aee042024-10-16WarningsExact identifier
application number: M013
ASPIRINASPIRINFSA Store Inc.062e7b7b-d052-82b0-e063-6294a90a7cce2024-10-16WarningsExact identifier
application number: M013
Acetaminophen PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEFSA STORE INC.f4322f34-ac19-371e-e053-2a95a90ac8642024-10-16WarningsExact identifier
application number: M013
Low dose Chewable AspirinASPIRINFSA STORE INC.f939b44c-93b6-ca61-e053-6394a90ae5862024-10-16WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENDISCOUNT DRUG MART850b5ad8-8774-413c-ae38-022215a94f952024-10-16WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINDISCOUNT DRUG MARTaf0f50d2-3e2d-f723-e053-2995a90a0d4b2024-10-16WarningsExact identifier
application number: M013
Enteric Coated AspirinASPIRINDISCOUNT DRUG MART03ed19dd-1cfc-47d5-b83e-ffa2ebe93f482024-10-16WarningsExact identifier
application number: M013
PAIN RELIEF Regular StrengthACETAMINOPHENAMERICAN SALES COMPANY2e3eabc8-193b-4397-a43c-db838eb16e672024-10-15WarningsExact identifier
application number: M013
Chewable AspirinASPIRINRETAIL BUSINESS SERVICES , LLC.c94d68ea-7f25-881f-e053-2995a90aa47f2024-10-15WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINRETAIL BUSINESS SERVICES , LLC.c94d750e-5a85-77f5-e053-2995a90a69152024-10-15WarningsExact 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