Handy Solutions Cold Relief

Product NDC
67751-177
Requested package NDC
67751-177-05
11-digit product format
677510177
Labeler code
67751
Product ID
67751-177_f18a9208-274c-2f1f-e053-2995a90a5f30
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Navajo Manufacturing Company Inc.
Application
M012
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2016-10-22
Marketing end
2024-01-01
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage67751-17767751-177-05DDiscontinued by firm2026-10-27

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 75 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HEB Honey Lemon Cough DropsMENTHOLHEBc19a79bc-9872-2e87-e053-2a95a90a94272025-12-13WarningsExact identifier
application number: M012
Cold and Flu Daytime NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCLWALMART INC.26f55169-4b37-4a36-88ee-064d6e9620652025-12-12WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWalgreen Company39ce76a3-b7a8-43be-9b61-5c1446cd9e902025-12-12WarningsExact identifier
application number: M012
Cold and Flu maximum strengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporationac01206f-a717-4c0b-8a03-fab0a4fd154b2025-12-12WarningsExact identifier
application number: M012
Sinus SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLStrategic Sourcing Services LLCdcb80dd5-465d-4792-947a-3044e25a52842025-12-12WarningsExact identifier
application number: M012
Vapor RubCOUGH SUPPRESSANTNeilmed Pharmaceuticals Inc.39190f9f-8a5a-e4d8-e063-6294a90a57dd2025-12-12WarningsExact identifier
application number: M012
Allergy Relief, 24-7 Life by 7-ElevenDIPHENHYDRAMINE HCL TABLET, FILM COATEDLil' Drug Store Products, Inc.45c4cd6c-327d-5950-e063-6394a90a3a212025-12-12WarningsExact identifier
application number: M012
Menthol cough dropsMENTHOLFamily Dollar44bb3b95-b2ba-470e-e054-00144ff88e882025-12-12WarningsExact identifier
application number: M012
menthol cough dropsMENTHOLFamily Dollar44bb9c7b-994b-4ab8-e054-00144ff8d46c2025-12-12WarningsExact identifier
application number: M012
cherry cough dropsMENTHOLFamily Dollar44be9837-f15a-09f2-e054-00144ff8d46c2025-12-12WarningsExact identifier
application number: M012
cherry cough dropsMENTHOLFamily Dollar44bcae39-2389-09ee-e054-00144ff8d46c2025-12-12WarningsExact identifier
application number: M012
honey lemon cough dropsMENTHOLFamily Dollar46635813-66c4-504c-e054-00144ff8d46c2025-12-12WarningsExact identifier
application number: M012
honey lemon cough dropsMENTHOLFamily Dollar455b0f4b-0526-2361-e054-00144ff8d46c2025-12-12WarningsExact identifier
application number: M012
Family Wellness Strawberry Cough DropsMENTHOLFamily Dollarf92466ac-dd93-9ac5-e053-6294a90a92912025-12-12WarningsExact identifier
application number: M012
GoodSense Menthol Cough DropsMENTHOLGeiss, Destin, Dunnc6b25d69-8930-6867-e053-2a95a90ad2082025-12-12WarningsExact identifier
application number: M012
Good Sense Cherry Cough DropsMENTHOLGeiss, Destin, Dunnc72db7f0-9324-8ed2-e053-2995a90a98682025-12-12WarningsExact identifier
application number: M012
Good Sense Honey Lemon Cough DropsMENTHOLGeiss, Destin, Dunnc72e557f-0211-81b9-e053-2995a90a14372025-12-12WarningsExact identifier
application number: M012
Good Sense Cherry Benzocaine LozengesBENZOCAINEGeiss, Destin, Dunnc7404c94-09eb-5cc5-e053-2995a90af0212025-12-12WarningsExact identifier
application number: M012
Good Sense SF Honey Lemon Cough DropsMENTHOLGeiss, Destin, Dunne11ed21f-6ceb-5908-e053-2995a90aea462025-12-12WarningsExact identifier
application number: M012
Severe Congestion Relief Maximum Strength SinusACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLWal-Mart Stores Inc59918b8b-5c91-468f-834e-66020dc1ae122025-12-12WarningsExact identifier
application number: M012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67751-177-05677510177053 POUCH in 1 CARTON (67751-177-05) > 2 TABLET in 1 POUCH3 pouch2016-10-222024-01-01NoNoCurrent