Pain Reliever PM

Product NDC
0363-4470
11-digit product format
003634470
Labeler code
0363
Product ID
0363-4470_4c5dc5bb-27fe-4e52-b691-c30733a931f9
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine HCl
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Walgreens
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-12-30
Marketing end
2025-11-30
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
500 mg/1; mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-4470-10EA - Each0363-4470a915cdb6-5d81-44c9-9d45-0572c95feef912022-06-06
0363-4470-15EA - Each0363-4470069c7dbe-b79d-49c9-85d1-23369a3f187012022-06-06
0363-4470-24EA - Each0363-4470c6ddced5-290b-4afc-8ff4-4736d3d5338612022-06-06
0363-4470-52EA - Each0363-4470b3b01bb7-58fb-4245-ade8-8fd19e83a2fb12022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [WALGREENS]2
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [WALGREENS]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [WALGREENS]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [WALGREENS]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [WALGREENS]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [WALGREENS]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [WALGREENS]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [WALGREENS]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [WALGREENS]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [WALGREENS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [WALGREENS]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [WALGREENS]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [WALGREENS]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [WALGREENS]2
POVIDONE K30INACTIVE INGREDIENTU725QWY32XPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [WALGREENS]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [WALGREENS]2
SODIUM STARCH GLYCOLATE TYPE A CORNINACTIVE INGREDIENTAG9B65PV6BPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [WALGREENS]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [WALGREENS]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [WALGREENS]2
TALCINACTIVE INGREDIENT7SEV7J4R1UPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [WALGREENS]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [WALGREENS]2
WATERINACTIVE INGREDIENT059QF0KO0RPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [WALGREENS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-4470PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [WALGREENS]8Legacy NDC20230120_c64cace3-ac67-41a3-95f5-c9fae581dfc8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-4470-10003634470101 BOTTLE, PLASTIC in 1 BOX (0363-4470-10) > 100 TABLET, COATED in 1 BOTTLE, PLASTIC2014-12-300000-00-00NoNoCurrent
0363-4470-11003634470111 BOTTLE, PLASTIC in 1 BOX (0363-4470-11) > 110 TABLET, COATED in 1 BOTTLE, PLASTIC2014-12-300000-00-00NoNoCurrent
0363-4470-15003634470151 BOTTLE, PLASTIC in 1 BOX (0363-4470-15) > 150 TABLET, COATED in 1 BOTTLE, PLASTIC2014-12-300000-00-00NoNoCurrent
0363-4470-24003634470241 BOTTLE, PLASTIC in 1 BOX (0363-4470-24) > 24 TABLET, COATED in 1 BOTTLE, PLASTIC2014-12-300000-00-00NoNoCurrent
0363-4470-30003634470301 BOTTLE, PLASTIC in 1 BOX (0363-4470-30) > 30 TABLET, COATED in 1 BOTTLE, PLASTIC2014-12-300000-00-00NoNoCurrent
0363-4470-5200363447052250 TABLET, COATED in 1 BOTTLE, PLASTIC (0363-4470-52) 2014-12-300000-00-00NoNoCurrent