FDA.reportPublic FDA data

Sleep Aid

Product NDC
55910-916
11-digit product format
559100916
Labeler code
55910
Product ID
55910-916_2d558255-dc32-4360-8983-7f71778a8e61
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE
Route
ORAL
Labeler
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-12-27
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 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
Sleep Aid
Brand name suffix
Nighttime
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1020477

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
55910-916-12Sleep AidNighttime120 in 1 BOTTLE, PLASTICCAPSULE12010
55910-916-16Sleep AidNighttime16 in 1 CARTONCAPSULE1610
55910-916-16Sleep AidNighttime1 in 1 BLISTER PACKCAPSULE110
55910-916-32Sleep AidNighttime32 in 1 BOTTLE, PLASTICCAPSULE3210
55910-916-32Sleep AidNighttime1 in 1 BOXCAPSULE110
55910-916-64Sleep AidNighttime1 in 1 BOXCAPSULE110
55910-916-64Sleep AidNighttime64 in 1 BOTTLE, PLASTICCAPSULE6410
55910-916-96Sleep AidNighttime96 in 1 BOTTLE, PLASTICCAPSULE9610

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-916SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) CAPSULE [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]7Current NDC, Legacy NDC, 8 package rows20240229_8dc17b5d-1cf7-44d2-9e78-d2c6952c7d20.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN8dc17b5d-1cf7-44d2-9e78-d2c6952c7d2010
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD8dc17b5d-1cf7-44d2-9e78-d2c6952c7d2010
1020477diphenhydramine HCl 50 MG Oral CapsuleSY8dc17b5d-1cf7-44d2-9e78-d2c6952c7d2010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-916-1255910091612120 CAPSULE in 1 BOTTLE, PLASTIC (55910-916-12) 120 capsule2019-12-27NoNoCurrent
55910-916-165591009161616 BLISTER PACK in 1 CARTON (55910-916-16) / 1 CAPSULE in 1 BLISTER PACK16 blister pack2019-12-270000-00-00NoNoCurrent
55910-916-32559100916321 BOTTLE, PLASTIC in 1 BOX (55910-916-32) / 32 CAPSULE in 1 BOTTLE, PLASTIC2019-12-270000-00-00NoNoCurrent
55910-916-64559100916641 BOTTLE, PLASTIC in 1 BOX (55910-916-64) / 64 CAPSULE in 1 BOTTLE, PLASTIC2019-12-270000-00-00NoNoCurrent
55910-916-965591009169696 CAPSULE in 1 BOTTLE, PLASTIC (55910-916-96) 96 capsule2019-12-270000-00-00NoNoCurrent