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 3 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Headache Formula Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEARMY AND AIR FORCE EXCHANGE SERVICEee8d0961-7572-471f-8c96-b4c0bd354de22026-08-18WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENRugby Laboratories76f10ee2-1d6a-097c-e053-2991aa0af5262026-08-18WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENMajor Pharmaceuticals780aad35-d0f1-44b1-e053-2991aa0af9a72026-08-18WarningsExact identifier
application number: M013
CHILDRENS PAIN AND FEVERACETAMINOPHENAmazon.com Services LLC5eacbc4f-d20a-4c22-9680-4a648e24de432026-08-18WarningsExact identifier
application number: M013
Pain Relief ChildrensACETAMINOPHENWinCo Foods, LLC15921c3f-e8d4-4794-983f-63bb926f6f862026-08-15WarningsExact identifier
application number: M013
Childrens Pain plus Fever ReliefACETAMINOPHENCVS PHARMACYe4cbfb06-d826-4d08-95d6-60305c4176252026-08-14WarningsExact identifier
application number: M013
Childrens Pain ReliefACETAMINOPHENCVS Pharmacy,Inc.3738d35c-1e83-40df-9292-c54e6b2c83532026-08-14WarningsExact identifier
application number: M013
CVS Childrens Pain plus Fever ReliefACETAMINOPHENCVS PHARMACY22a48a33-995b-481e-9e4e-1ad7ec346f442026-08-14WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINECVS Pharmacy31ccc867-ca83-70a9-f3d5-5644030047b82026-08-13WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENTopco Associates, LLC8b9e90da-98e2-4d8d-bf6e-54b0a8f8d1012026-08-12WarningsExact identifier
application number: M013
Aspirin 81mgASPIRINHARRIS TEETER54e69d5a-55d7-4ebe-8494-0be93613f1e22026-08-12WarningsExact identifier
application number: M013
Chewable AspirinASPIRINHARRIS TEETERc6a28c83-60c9-3304-e053-2a95a90aa06c2026-08-12WarningsExact identifier
application number: M013
ASPIRINASPIRINHARRIS TEETER93cbd3cb-1072-89e6-e053-2995a90a2f152026-08-12WarningsExact identifier
application number: M013
Adult Chewable AspirinASPIRINHARRIS TEETERc6a28617-1769-7a7d-e053-2995a90a1ea02026-08-12WarningsExact identifier
application number: M013
Gencare- Pain Relief AcetaminophenACETAMINOPHENPioneer Life Sciences, LLC2111c91b-2fd7-4ab3-946a-d4e0cf46399a2026-08-12WarningsExact identifier
application number: M013
Pain Reliever Extra StrengthACETAMINOPHENSalado Sales, Inc.1dbd8480-5cb4-4577-9091-b2a2add4f1af2026-08-12WarningsExact identifier
application number: M013
pain relief childrensACETAMINOPHENRite Aid Corporation29ecdd2d-aeaf-40a8-a347-011088009ea62026-08-11WarningsExact identifier
application number: M013
Fast Acting Pedia CraeACETAMINOPHENRandob Labs., Ltd.e069060f-fbb2-4c7a-b872-00b3ab86d01b2026-08-11WarningsExact identifier
application number: M013
ASPIRINASPIRINAmazon.com Services LLCc7cc0681-4c0b-4565-99df-d0168c8ba1ba2026-08-10WarningsExact identifier
application number: M013
GenCare Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEPioneer Life Sciences, LLCac8c4bdf-30c9-2b09-e053-2a95a90a9b672026-08-09WarningsExact 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