FDA.reportPublic FDA data

Vicks NyQuil Severe

Product NDC
37000-518
11-digit product format
370000518
Labeler code
37000
Product ID
37000-518_4a172e6a-952f-dd6a-e063-6294a90a8484
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide, and Doxylamine Succinate
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-07-10
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Vicks NyQuil Severe
Brand name suffix
Cold and Flu
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
DEXTROMETHORPHAN HYDROBROMIDE10 mg/1
DOXYLAMINE SUCCINATE6.25 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 9D2RTI9KYH, V9BI9B5YI2, 04JA59TNSJ
Rxcui1297288

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37000-518-022024-01-30C16284748780-1ba0f9c33-31ad-a910-e053-dadaa90a0b85VICKS ® NyQuil™ Severe COLD & FLU Liquicaps
37000-518-082024-01-30C16284748780-1ba0f9c33-31ad-a910-e053-dadaa90a0b85VICKS ® NyQuil™ Severe COLD & FLU Liquicaps
37000-518-242024-01-30C16284748780-1ba0f9c33-31ad-a910-e053-dadaa90a0b85VICKS ® NyQuil™ Severe COLD & FLU Liquicaps
37000-518-082021-02-11C16284748780-1ba0f9c33-31ad-a910-e053-dadaa90a0b85VICKS ® NyQuil™ Severe COLD & FLU Liquicaps
37000-518-242021-02-11C16284748780-1ba0f9c33-31ad-a910-e053-dadaa90a0b85VICKS ® NyQuil™ Severe COLD & FLU Liquicaps
37000-518-082021-01-29C16284748780-1ba0f9c33-31ad-a910-e053-dadaa90a0b85VICKS ® NyQuil™ Severe COLD & FLU Liquicaps
37000-518-242021-01-29C16284748780-1ba0f9c33-31ad-a910-e053-dadaa90a0b85VICKS ® NyQuil™ Severe COLD & FLU Liquicaps

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-518-02Vicks NyQuil SevereCold and Flu2 in 1 POUCHCAPSULE, LIQUID FILLED218
37000-518-08Vicks NyQuil SevereCold and Flu1 in 1 CARTONCAPSULE, LIQUID FILLED118
37000-518-08Vicks NyQuil SevereCold and Flu8 in 1 BLISTER PACKCAPSULE, LIQUID FILLED818
37000-518-24Vicks NyQuil SevereCold and Flu2 in 1 CARTONCAPSULE, LIQUID FILLED218
37000-518-24Vicks NyQuil SevereCold and Flu12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1218

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37000-518VICKS NYQUIL SEVERE COLD AND FLU (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [THE PROCTER & GAMBLE MANUFACTURING COMPANY]14Current NDC, Legacy NDC, 5 package rows20241012_6eef8a59-2f8a-1a90-e053-2a91aa0a1d52.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1297288acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral CapsulePSN6eef8a59-2f8a-1a90-e053-2a91aa0a1d5218
1297288acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD6eef8a59-2f8a-1a90-e053-2a91aa0a1d5218
1297288APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSY6eef8a59-2f8a-1a90-e053-2a91aa0a1d5218
2634364{1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule) } PackGPCK9003df61-5d82-5c4d-e053-2995a90a899911
26343641 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule) PackPSN9003df61-5d82-5c4d-e053-2995a90a899911
1297288acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral CapsulePSN9003df61-5d82-5c4d-e053-2995a90a899911
1656815acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral CapsulePSN9003df61-5d82-5c4d-e053-2995a90a899911
1297288acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD9003df61-5d82-5c4d-e053-2995a90a899911
1656815acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD9003df61-5d82-5c4d-e053-2995a90a899911
26343641 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule) PackSY9003df61-5d82-5c4d-e053-2995a90a899911
1297288APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSY9003df61-5d82-5c4d-e053-2995a90a899911
1656815APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSY9003df61-5d82-5c4d-e053-2995a90a899911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37000-518-02370000518022 CAPSULE, LIQUID FILLED in 1 POUCH (37000-518-02) 2021-01-010000-00-00NoNoCurrent
37000-518-08370000518081 BLISTER PACK in 1 CARTON (37000-518-08) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2019-07-010000-00-00NoNoCurrent
37000-518-12370000518121 BLISTER PACK in 1 CARTON (37000-518-12) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2019-07-010000-00-00NoNoCurrent
37000-518-24370000518242 BLISTER PACK in 1 CARTON (37000-518-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2018-07-100000-00-00NoNoCurrent