DORMMY-LON

Product NDC
83164-000
11-digit product format
831640000
Labeler code
83164
Product ID
83164-000_4960ab74-45e1-6df7-e063-6394a90ac2d9
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Haendel Farma, S.A. de C.V.
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-01-04
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DORMMY-LON
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1049630

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83164-000-012024-07-30C16284748780-11030e365-1b4b-111a-e063-dadaa90a10e2DORMMY-LON
83164-000-012024-01-30C16284748780-11030e365-1b4b-111a-e063-dadaa90a10e2DORMMY-LON

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83164-000-01DORMMY-LON60 in 1 BOTTLETABLET603
83164-000-01DORMMY-LON1 in 1 BOXTABLET13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83164-000DORMMY-LON (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [HAENDEL FARMA, S.A. DE C.V.]2Current NDC, 2 package rows20230124_562db961-83cb-4b74-9f34-fecee2c1be17.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN562db961-83cb-4b74-9f34-fecee2c1be173
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD562db961-83cb-4b74-9f34-fecee2c1be173

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83164-000-01831640000011 BOTTLE in 1 BOX (83164-000-01) / 60 TABLET in 1 BOTTLE1 bottle2023-01-04NoNoHistorical