Extra Strength NiteTime Pain Relief

Product NDC
0363-0714
11-digit product format
003630714
Labeler code
0363
Product ID
0363-0714_3ac05a52-7cce-2bfb-e063-6394a90a134b
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen 500 mg,Diphenhydramine Hydrochloride 25 mg Tablet
Dosage form
TABLET
Route
ORAL
Labeler
WALGREENS
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-10-12
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
Extra Strength NiteTime Pain Relief
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

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0714-42Extra Strength NiteTime Pain Relief24 in 1 BOTTLETABLET245
0363-0714-42Extra Strength NiteTime Pain Relief1 in 1 CARTONTABLET15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0714EXTRA STRENGTH NITETIME PAIN RELIEF (ACETAMINOPHEN 500 MG,DIPHENHYDRAMINE HYDROCHLORIDE 25 MG TABLET) TABLET [WALGREENS]4Current NDC, Legacy NDC, 2 package rows20250210_c25c75c7-157f-1c0d-e053-2995a90a2e3c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSNc25c75c7-157f-1c0d-e053-2995a90a2e3c5
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCDc25c75c7-157f-1c0d-e053-2995a90a2e3c5
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSYc25c75c7-157f-1c0d-e053-2995a90a2e3c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0714-42003630714421 BOTTLE in 1 CARTON (0363-0714-42) / 24 TABLET in 1 BOTTLE1 bottle2021-10-120000-00-00NoNoCurrent