FDA.reportPublic FDA data

Vicks ZzzQuil

Product NDC
69423-902
11-digit product format
694230902
Labeler code
69423
Product ID
69423-902_402e64c4-5771-d190-e063-6294a90a7fe2
Type
HUMAN OTC DRUG
Nonproprietary name
Doxylamine succinate
Dosage form
TABLET
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
ANDA040167
Marketing category
ANDA
Marketing start
2021-03-01
Substance
DOXYLAMINE SUCCINATE
Active strength
25 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Vicks ZzzQuil
Brand name suffix
Ultra
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYLAMINE SUCCINATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV9BI9B5YI2
Rxcui1101446, 2548540

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69423-902-012024-01-30C16284748780-11030e365-088a-111a-e063-dadaa90a10e2Vicks ZzzQuil Ultra
69423-902-122024-01-30C16284748780-11030e365-088a-111a-e063-dadaa90a10e2Vicks ZzzQuil Ultra
69423-902-242024-01-30C16284748780-11030e365-088a-111a-e063-dadaa90a10e2Vicks ZzzQuil Ultra
69423-902-322024-01-30C16284748780-11030e365-088a-111a-e063-dadaa90a10e2Vicks ZzzQuil Ultra
69423-902-482024-01-30C16284748780-11030e365-088a-111a-e063-dadaa90a10e2Vicks ZzzQuil Ultra

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-902-01Vicks ZzzQuilUltra1 in 1 POUCHTABLET114
69423-902-12Vicks ZzzQuilUltra12 in 1 BLISTER PACKTABLET1214
69423-902-12Vicks ZzzQuilUltra1 in 1 CARTONTABLET114
69423-902-24Vicks ZzzQuilUltra2 in 1 CARTONTABLET214
69423-902-24Vicks ZzzQuilUltra12 in 1 BLISTER PACKTABLET1214
69423-902-32Vicks ZzzQuilUltra1 in 1 POUCHTABLET114
69423-902-32Vicks ZzzQuilUltra32 in 1 CARTONTABLET3214
69423-902-48Vicks ZzzQuilUltra4 in 1 CARTONTABLET414
69423-902-48Vicks ZzzQuilUltra12 in 1 BLISTER PACKTABLET1214

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-902VICKS ZZZQUIL ULTRA (DOXYLAMINE SUCCINATE) TABLET [THE PROCTER & GAMBLE MANUFACTURING COMPANY]13Current NDC, Legacy NDC, 9 package rows20241012_c29f6f9a-7b55-30c3-e053-2995a90a9de7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1101446doxylamine succinate 25 MG Oral TabletPSNc29f6f9a-7b55-30c3-e053-2995a90a9de714
2548540Zzzquil Ultra 25 MG Oral TabletPSNc29f6f9a-7b55-30c3-e053-2995a90a9de714
2548540doxylamine succinate 25 MG Oral Tablet [Zzzquil Ultra]SBDc29f6f9a-7b55-30c3-e053-2995a90a9de714
1101446doxylamine succinate 25 MG Oral TabletSCDc29f6f9a-7b55-30c3-e053-2995a90a9de714
2548540Zzzquil Ultra 25 MG Oral TabletSYc29f6f9a-7b55-30c3-e053-2995a90a9de714

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69423-902-01694230902011 TABLET in 1 POUCH (69423-902-01) 1 tablet2023-10-16NoNoCurrent
69423-902-12694230902121 BLISTER PACK in 1 CARTON (69423-902-12) / 12 TABLET in 1 BLISTER PACK1 blister pack2021-03-010000-00-00NoNoCurrent
69423-902-24694230902242 BLISTER PACK in 1 CARTON (69423-902-24) / 12 TABLET in 1 BLISTER PACK2 blister pack2021-03-010000-00-00NoNoCurrent
69423-902-326942309023232 POUCH in 1 CARTON (69423-902-32) / 1 TABLET in 1 POUCH32 pouch2023-10-16NoNoCurrent
69423-902-48694230902484 BLISTER PACK in 1 CARTON (69423-902-48) / 12 TABLET in 1 BLISTER PACK4 blister pack2021-03-010000-00-00NoNoCurrent