Nytol

Product NDC
63029-211
11-digit product format
630290211
Labeler code
63029
Product ID
63029-211_44ddd1a5-3a3d-4b67-b48a-fbadde98258d
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
TABLET
Route
ORAL
Labeler
Medtech Products Inc.
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-06-01
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 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
Nytol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1049630, 1092416

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
63029-211-01Nytol8 in 1 BLISTER PACKTABLET84
63029-211-01Nytol4 in 1 BOXTABLET44
63029-211-02Nytol8 in 1 BLISTER PACKTABLET84
63029-211-02Nytol2 in 1 BOXTABLET24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63029-211NYTOL (DIPHENHYDRAMINE HCL) TABLET [MEDTECH PRODUCTS INC.]4Current NDC, Legacy NDC, 4 package rows20241213_c81d018a-0170-4396-81e9-2e13a53f868a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSNc81d018a-0170-4396-81e9-2e13a53f868a4
1092416Nytol 25 MG Oral TabletPSNc81d018a-0170-4396-81e9-2e13a53f868a4
1092416diphenhydramine hydrochloride 25 MG Oral Tablet [Nytol]SBDc81d018a-0170-4396-81e9-2e13a53f868a4
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCDc81d018a-0170-4396-81e9-2e13a53f868a4
1092416Nytol 25 MG Oral TabletSYc81d018a-0170-4396-81e9-2e13a53f868a4
1092416Nytol Quickcaps 25 MG Oral TabletSYc81d018a-0170-4396-81e9-2e13a53f868a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63029-211-01630290211014 BLISTER PACK in 1 BOX (63029-211-01) / 8 TABLET in 1 BLISTER PACK4 blister pack2012-06-010000-00-00NoNoCurrent
63029-211-02630290211022 BLISTER PACK in 1 BOX (63029-211-02) / 8 TABLET in 1 BLISTER PACK2 blister pack2012-06-010000-00-00NoNoCurrent