Panadol

Product NDC
0135-7034
11-digit product format
001357034
Labeler code
0135
Product ID
0135-7034_509e32fe-7608-69c1-e063-6394a90a0dc0
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, chlorpheniramine maleate, dextromethorphan HBr
Dosage form
TABLET
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-04-30
Substance
ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
500; 2; 15 mg/1; mg/1; mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Panadol
Brand name suffix
Cold and Flu Night
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1
CHLORPHENIRAMINE MALEATE2 mg/1
DEXTROMETHORPHAN HYDROBROMIDE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, V1Q0O9OJ9Z, 9D2RTI9KYH
Rxcui1098496

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
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16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
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103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
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22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
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c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
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e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-7034-20PanadolCold and Flu Night10 in 1 BLISTER PACKTABLET102
0135-7034-20PanadolCold and Flu Night2 in 1 CARTONTABLET22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1098496acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 15 MG Oral TabletPSN3417993d-8e3c-23d6-e063-6394a90a7d502
1098496acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG Oral TabletSCD3417993d-8e3c-23d6-e063-6394a90a7d502
1098496APAP 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG Oral TabletSY3417993d-8e3c-23d6-e063-6394a90a7d502

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0135-7034-20001357034202 BLISTER PACK in 1 CARTON (0135-7034-20) / 10 TABLET in 1 BLISTER PACK2 blister pack2026-04-30NoNoHistorical