PANADOL

Product NDC
0135-7021
11-digit product format
001357021
Labeler code
0135
Product ID
0135-7021_10c195cf-3021-2052-e063-6294a90a1ea0
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen and diphenhydramine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-06-25
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
500; 25 mg/1; mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, TC2D6JAD40
Rxcui1092189, 1094718

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-7021-01PANADOLPM50 in 1 CARTONTABLET, FILM COATED504
0135-7021-01PANADOLPM2 in 1 PACKETTABLET, FILM COATED24
0135-7021-02PANADOLPM1 in 1 CARTONTABLET, FILM COATED14
0135-7021-02PANADOLPM24 in 1 BOTTLETABLET, FILM COATED244
0135-7021-03PANADOLPM50 in 1 BOTTLETABLET, FILM COATED504
0135-7021-03PANADOLPM1 in 1 CARTONTABLET, FILM COATED14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-7021PANADOL PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, FILM COATED [HALEON US HOLDINGS LLC]4Current NDC, Legacy NDC, 6 package rows20240207_fe7cd1f2-9b00-4ded-99c2-8a152c71093c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSNfe7cd1f2-9b00-4ded-99c2-8a152c71093c4
1094718Panadol PM EXTRA STRENGTH 500 MG / 25 MG Oral TabletPSNfe7cd1f2-9b00-4ded-99c2-8a152c71093c4
1094718acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet [Panadol PM]SBDfe7cd1f2-9b00-4ded-99c2-8a152c71093c4
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCDfe7cd1f2-9b00-4ded-99c2-8a152c71093c4
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSYfe7cd1f2-9b00-4ded-99c2-8a152c71093c4
1094718APAP 500 MG / Diphenhydramine Hydrochloride 25 MG Oral Tablet [Panadol PM]SYfe7cd1f2-9b00-4ded-99c2-8a152c71093c4
1094718Panadol PM (APAP 500 MG / diphenhydramine hydrochloride 25 MG) Oral TabletSYfe7cd1f2-9b00-4ded-99c2-8a152c71093c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-7021-010013570210150 PACKET in 1 CARTON (0135-7021-01) / 2 TABLET, FILM COATED in 1 PACKET50 packet2022-05-190000-00-00NoNoCurrent
0135-7021-02001357021021 BOTTLE in 1 CARTON (0135-7021-02) / 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-12-070000-00-00NoNoCurrent
0135-7021-03001357021031 BOTTLE in 1 CARTON (0135-7021-03) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-12-070000-00-00NoNoCurrent