FDA.reportPublic FDA data

NyQuil Severe Cold and Flu

Product NDC
73097-009
11-digit product format
730970009
Labeler code
73097
Product ID
73097-009_8de6a5b5-0a1f-29df-e053-2a95a90af75e
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Savings Distributors LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-07-08
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325 mg/1; mg/1; mg/1; mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
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
73097-009-022021-01-29C16284748780-1ba0f9c33-1356-a910-e053-dadaa90a0b85NyQuil Severe Cold & Flu
73097-009-202021-01-29C16284748780-1ba0f9c33-1356-a910-e053-dadaa90a0b85NyQuil Severe Cold & Flu
73097-009-252021-01-29C16284748780-1ba0f9c33-1356-a910-e053-dadaa90a0b85NyQuil Severe Cold & Flu

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73097-009-02NyQuil Severe Cold and Flu1 in 1 CARTONTABLET, COATED11
73097-009-02NyQuil Severe Cold and Flu2 in 1 POUCHTABLET, COATED21
73097-009-20NyQuil Severe Cold and Flu40 in 1 CARTONTABLET, COATED401
73097-009-20NyQuil Severe Cold and Flu2 in 1 POUCHTABLET, COATED21
73097-009-25NyQuil Severe Cold and Flu2 in 1 POUCHTABLET, COATED21
73097-009-25NyQuil Severe Cold and Flu50 in 1 CARTONTABLET, COATED501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73097-009NYQUIL SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [SAVINGS DISTRIBUTORS LLC]1Legacy NDC, 6 package rows20190719_8de6c330-fae4-438c-e053-2a95a90ab640.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1546881acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral TabletPSN8de6c330-fae4-438c-e053-2a95a90ab6401
1546881acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD8de6c330-fae4-438c-e053-2a95a90ab6401
1546881APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSY8de6c330-fae4-438c-e053-2a95a90ab6401

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
73097-009-02730970009021 in 1 CARTONHistorical
73097-009-207309700092040 in 1 CARTONHistorical
73097-009-25730970009252 in 1 POUCHHistorical