Multi-Symptom Cold and Sinus

Product NDC
49035-561
Requested package NDC
49035-561-01
11-digit product format
490350561
Labeler code
49035
Product ID
49035-561_6ada4759-ee39-4a10-a74a-2130f8194595
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Guaifenesin, Phenylephrine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Wal-Mart Stores Inc
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-06-30
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325 mg/1; mg/1; mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
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 packagepackage49035-56149035-561-01DDiscontinued by firm2026-10-15

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.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DMULTI-SYMPTOM COLD AND SINUS MAXIMUM STRENGTH (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]2
GUAIFENESINACTIVE INGREDIENT495W7451VQMULTI-SYMPTOM COLD AND SINUS MAXIMUM STRENGTH (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJMULTI-SYMPTOM COLD AND SINUS MAXIMUM STRENGTH (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DMULTI-SYMPTOM COLD AND SINUS MAXIMUM STRENGTH (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]2
GUAIFENESINACTIVE MOIETY495W7451VQMULTI-SYMPTOM COLD AND SINUS MAXIMUM STRENGTH (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVMULTI-SYMPTOM COLD AND SINUS MAXIMUM STRENGTH (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMULTI-SYMPTOM COLD AND SINUS MAXIMUM STRENGTH (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8MULTI-SYMPTOM COLD AND SINUS MAXIMUM STRENGTH (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MULTI-SYMPTOM COLD AND SINUS MAXIMUM STRENGTH (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]2
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DMULTI-SYMPTOM COLD AND SINUS MAXIMUM STRENGTH (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990MULTI-SYMPTOM COLD AND SINUS MAXIMUM STRENGTH (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMULTI-SYMPTOM COLD AND SINUS MAXIMUM STRENGTH (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]2
TALCINACTIVE INGREDIENT7SEV7J4R1UMULTI-SYMPTOM COLD AND SINUS MAXIMUM STRENGTH (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-561-01490350561013 BLISTER PACK in 1 PACKAGE (49035-561-01) > 10 TABLET, FILM COATED in 1 BLISTER PACK3 blister pack2013-06-300000-00-00NoNoCurrent