Nighttime Sleep Aid

Product NDC
70677-1128
11-digit product format
706771128
Labeler code
70677
Product ID
70677-1128_e0e47664-4cf3-4a1a-8f24-719634571544
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-05-18
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
Nighttime Sleep Aid
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-1128-1Nighttime Sleep Aid2 in 1 CARTONTABLET, FILM COATED25
70677-1128-1Nighttime Sleep Aid12 in 1 BLISTER PACKTABLET, FILM COATED125

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1128-1EA - Each70677-1128c86bdedf-c96f-45e3-9e4d-ad1b4945aa7612023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1128NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [STRATEGIC SOURCING SERVICES LLC]4Current NDC, 2 package rows20250512_e68d96c8-21c5-406c-b22c-3e384027c79f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSNe68d96c8-21c5-406c-b22c-3e384027c79f5
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCDe68d96c8-21c5-406c-b22c-3e384027c79f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70677-1128-1706771128012 BLISTER PACK in 1 CARTON (70677-1128-1) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2023-05-18NoNoHistorical