FDA.reportPublic FDA data

PANADOL

Product NDC
0135-0539
11-digit product format
001350539
Labeler code
0135
Product ID
0135-0539_10c14ee5-017b-0434-e063-6394a90af0f4
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

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
PANADOL
Listing expiration
2026-12-31

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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
95801755-db54-4ad7-bec1-52671914f6caAvailable on FDA.report

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
0135-0539-02PANADOL1 in 1 CARTONSUSPENSION110
0135-0539-02PANADOL54.7 mL in 1 BOTTLESUSPENSION54.710

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0539-02ML - Milliliter0135-05391aeed3ea-dda0-40d1-9b63-f192898d2f3e12022-12-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DPANADOL (ACETAMINOPHEN) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
ACETAMINOPHENACTIVE MOIETY362O9ITL9DPANADOL (ACETAMINOPHEN) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMPANADOL (ACETAMINOPHEN) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPANADOL (ACETAMINOPHEN) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPANADOL (ACETAMINOPHEN) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBPANADOL (ACETAMINOPHEN) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APANADOL (ACETAMINOPHEN) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4PANADOL (ACETAMINOPHEN) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PANADOL (ACETAMINOPHEN) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPANADOL (ACETAMINOPHEN) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPANADOL (ACETAMINOPHEN) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
SORBITOLINACTIVE INGREDIENT506T60A25RPANADOL (ACETAMINOPHEN) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
WATERINACTIVE INGREDIENT059QF0KO0RPANADOL (ACETAMINOPHEN) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0539PANADOL (ACETAMINOPHEN) SUSPENSION [HALEON US HOLDINGS LLC]10Current NDC, Legacy NDC, 2 package rows20240207_95801755-db54-4ad7-bec1-52671914f6ca.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 11 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens MapapACETAMINOPHENMajor Pharmaceuticalsefec6af2-8b26-47f6-88c8-b0a6d69a2d7d2026-06-03WarningsExact identifier
application number: M013
Acetaminophen PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLUnited Natural Foods, Inc. dba UNFIae3114c3-8cfe-4b81-8ac7-c281fe68b4622026-06-03WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCOSTCO WHOLESALE CORPORATION3745aa18-a711-43ed-9bc4-1f087b3c53c02026-06-03WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLC3f653262-b931-7d42-e063-6394a90adddd2026-06-03WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWalgreen Company0b1bef50-7957-4ea1-9ae3-91f59ea2dbb42026-06-03WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLWALMART INC.42310898-cf3a-4ffb-88bb-b8b84449156e2026-06-02WarningsExact identifier
application number: M013
PAIN RELIEFACETAMINOPHENMeijer, Inc.1319bab8-8f17-44fb-9d91-099b0ba38a8d2026-06-01WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLFamily Dollar (FAMILY WELLNESS)7a98d4d9-54e2-45c1-a76a-7f1907566e952026-06-01WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENTIME CAP LABORATORIES, INC.58840cf4-aceb-c7cf-e063-6294a90a5ff42026-06-01WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENCVS Pharmacy832acd72-1dda-4490-978f-5f31748942df2026-06-01WarningsExact identifier
application number: M013
Acetaminophen PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEMajor Pharmaceuticals786dbcd5-f5c2-4491-e053-2991aa0a34372026-05-29WarningsExact identifier
application number: M013
Back and Body Extra StrengthASPIRIN, CAFFEINEMeijer Distribution Ince513f2d9-d591-4790-a117-6176ce2279dc2026-05-29WarningsExact identifier
application number: M013
Chewable Acetaminophen ChildrensACETAMINOPHENCardinal Health 110, LLC. DBA Leader5460a4b7-5da3-4fc2-a565-0b0dd11bbf442026-05-29WarningsExact identifier
application number: M013
Extra Strength Mini Softgels Pain RelieverACETAMINOPHENCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDf55d3663-7007-41cd-ae2d-5aca6311be812026-05-28WarningsExact identifier
application number: M013
Genexa Kids Pain and FeverACETAMINOPHENGenexa Inc.5130c695-a80e-2dd3-e063-6294a90a404f2026-05-28WarningsExact identifier
application number: M013
TYLENOL Regular StrengthACETAMINOPHENKenvue Brands LLC1622f694-4d63-4c56-8737-fae31f0ecfb72026-05-27WarningsExact identifier
application number: M013
INFANTS Pain and FeverACETAMINOPHENAurohealth LLC257436e1-e0f3-4a87-bffe-4f176b836caf2026-05-27WarningsExact identifier
application number: M013
Infants Pain and FeverACETAMINOPHENAurohealth LLC6509a545-0036-460a-8f0d-b31caae178552026-05-27WarningsExact identifier
application number: M013
Alka-Seltzer OriginalANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATESelect Consumer Group3ca80d74-1e8b-49d9-e063-6394a90a43122026-05-24WarningsExact identifier
application number: M013
Pain and Fever Chewables ChildrensACETAMINOPHENCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDbad8ac0a-518d-4639-9b92-a39e0d4372382026-05-22WarningsExact identifier
application number: M013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-0539-02001350539021 BOTTLE in 1 CARTON (0135-0539-02) / 54.7 mL in 1 BOTTLE1 bottle2012-10-150000-00-00NoNoCurrent