PANADOL

Product NDC
0135-0537
11-digit product format
001350537
Labeler code
0135
Product ID
0135-0537_10c0504e-269e-b058-e063-6394a90a5b84
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-10-15
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PANADOL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN160 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0537-01PANADOL15 mL in 1 BOTTLESUSPENSION1514
0135-0537-01PANADOL1 in 1 CARTONSUSPENSION114
0135-0537-02PANADOL54.7 mL in 1 BOTTLESUSPENSION54.714
0135-0537-02PANADOL1 in 1 CARTONSUSPENSION114
0135-0537-03PANADOL1 in 1 CARTONSUSPENSION114
0135-0537-03PANADOL118 mL in 1 BOTTLESUSPENSION11814

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0537-03ML - Milliliter0135-05374d37b28e-b7a6-4ed1-a89f-c37b76e475d412022-12-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DPANADOL (ACETAMINOPHEN) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]8
ACETAMINOPHENACTIVE MOIETY362O9ITL9DPANADOL (ACETAMINOPHEN) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]8
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMPANADOL (ACETAMINOPHEN) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]8
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPANADOL (ACETAMINOPHEN) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]8
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPANADOL (ACETAMINOPHEN) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]8
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBPANADOL (ACETAMINOPHEN) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]8
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APANADOL (ACETAMINOPHEN) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]8
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4PANADOL (ACETAMINOPHEN) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]8
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PANADOL (ACETAMINOPHEN) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]8
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPANADOL (ACETAMINOPHEN) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]8
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPANADOL (ACETAMINOPHEN) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]8
SORBITOLINACTIVE INGREDIENT506T60A25RPANADOL (ACETAMINOPHEN) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]8
WATERINACTIVE INGREDIENT059QF0KO0RPANADOL (ACETAMINOPHEN) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0537PANADOL (ACETAMINOPHEN) SUSPENSION [HALEON US HOLDINGS LLC]14Current NDC, Legacy NDC, 6 package rows20240207_e1799765-c247-42b4-ad6a-8ba7d136abf2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-0537-01001350537011 BOTTLE in 1 CARTON (0135-0537-01) / 15 mL in 1 BOTTLE1 bottle2012-10-150000-00-00NoNoCurrent
0135-0537-020013505370254.7 mL in 1 BOTTLE54.7 mlHistorical
0135-0537-03001350537031 BOTTLE in 1 CARTON (0135-0537-03) / 118 mL in 1 BOTTLE1 bottle2012-10-150000-00-00NoNoCurrent