Childrens Multi-symptom Cold

Product NDC
67091-220
Requested package NDC
67091-220-18
11-digit product format
670910220
Labeler code
67091
Product ID
67091-220_003f75b9-89b0-41a3-bbdf-bf70c251e39b
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
Dosage form
LIQUID
Route
ORAL
Labeler
WinCo Foods, LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-12-12
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
5 mg/5mL; mg/5mL; mg/5mL
NDC exclude flag
No
Listing certified through
2020-12-31
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 packagepackage67091-22067091-220-18IInactivated by FDA2026-10-05

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 · 15 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…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

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

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
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67091-220-182023-01-30C16284748780-1f386c649-fc0d-0266-e053-dadaa90a7c1aChildrens Multi-symptom Cold Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67091-220-18Childrens Multi-symptom Cold118 mL in 1 BOTTLELIQUID1182
67091-220-18Childrens Multi-symptom Cold1 in 1 CARTONLIQUID12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHCHILDRENS MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WINCO FOODS, LLC]1
GUAIFENESINACTIVE INGREDIENT495W7451VQCHILDRENS MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WINCO FOODS, LLC]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJCHILDRENS MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WINCO FOODS, LLC]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSCHILDRENS MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WINCO FOODS, LLC]1
GUAIFENESINACTIVE MOIETY495W7451VQCHILDRENS MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WINCO FOODS, LLC]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVCHILDRENS MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WINCO FOODS, LLC]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCHILDRENS MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WINCO FOODS, LLC]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LCHILDRENS MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WINCO FOODS, LLC]1
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2CHILDRENS MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WINCO FOODS, LLC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCHILDRENS MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WINCO FOODS, LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCHILDRENS MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WINCO FOODS, LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACHILDRENS MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WINCO FOODS, LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHILDRENS MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WINCO FOODS, LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCHILDRENS MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WINCO FOODS, LLC]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4CHILDRENS MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WINCO FOODS, LLC]1
PROPYL GALLATEINACTIVE INGREDIENT8D4SNN7V92CHILDRENS MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WINCO FOODS, LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CHILDRENS MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WINCO FOODS, LLC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCHILDRENS MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WINCO FOODS, LLC]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCHILDRENS MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WINCO FOODS, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICHILDRENS MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WINCO FOODS, LLC]1
SORBITOLINACTIVE INGREDIENT506T60A25RCHILDRENS MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WINCO FOODS, LLC]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4CHILDRENS MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WINCO FOODS, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RCHILDRENS MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WINCO FOODS, LLC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECHILDRENS MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WINCO FOODS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67091-220CHILDRENS MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WINCO FOODS, LLC]2Legacy NDC, 2 package rows20191210_3d09bfea-7f73-45ab-bb62-50e9bae90367.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043543dextromethorphan HBr 5 MG / guaiFENesin 100 MG / phenylephrine HCl 2.5 MG in 5 mL Oral SolutionPSN3d09bfea-7f73-45ab-bb62-50e9bae903672
1043543dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD3d09bfea-7f73-45ab-bb62-50e9bae903672
1043543dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral SolutionSY3d09bfea-7f73-45ab-bb62-50e9bae903672
1043543dextromethorphan HBr 5 MG / guaifenesin 100 MG / phenylephrine HCl 2.5 MG per 5 ML Oral SolutionSY3d09bfea-7f73-45ab-bb62-50e9bae903672

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67091-220-18670910220181 BOTTLE in 1 CARTON (67091-220-18) > 118 mL in 1 BOTTLE1 bottle2014-12-120000-00-00NoNoCurrent