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Product NDC
46122-271
11-digit product format
461220271
Labeler code
46122
Product ID
46122-271_575ee593-2e98-4f85-9344-cb44b43db328
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, guaifenesin, phenylephrine HCl
Dosage form
CAPSULE, COATED
Route
ORAL
Labeler
Amerisource Bergen
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-11-06
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
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct46122-271DDiscontinued by firm2026-10-12
excluded packagepackage46122-27146122-271-60DDiscontinued by firm2026-10-12

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage46122-271-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage46122-271-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage46122-271-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage46122-271-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage46122-271-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage46122-271-60cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage46122-271-60302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage46122-271-60ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage46122-271-600efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage46122-271-60ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage46122-271-60367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage46122-271-60557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-271-60EA - Each46122-2714b186619-88a6-4bfd-bbb9-4afe73a0687c12018-02-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DGOOD NEIGHBOR PHARMACY SINUS RELIEF (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) CAPSULE, COATED [AMERISOURCE BERGEN]2
GUAIFENESINACTIVE INGREDIENT495W7451VQGOOD NEIGHBOR PHARMACY SINUS RELIEF (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) CAPSULE, COATED [AMERISOURCE BERGEN]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJGOOD NEIGHBOR PHARMACY SINUS RELIEF (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) CAPSULE, COATED [AMERISOURCE BERGEN]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DGOOD NEIGHBOR PHARMACY SINUS RELIEF (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) CAPSULE, COATED [AMERISOURCE BERGEN]2
GUAIFENESINACTIVE MOIETY495W7451VQGOOD NEIGHBOR PHARMACY SINUS RELIEF (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) CAPSULE, COATED [AMERISOURCE BERGEN]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVGOOD NEIGHBOR PHARMACY SINUS RELIEF (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) CAPSULE, COATED [AMERISOURCE BERGEN]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGOOD NEIGHBOR PHARMACY SINUS RELIEF (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) CAPSULE, COATED [AMERISOURCE BERGEN]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48GOOD NEIGHBOR PHARMACY SINUS RELIEF (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) CAPSULE, COATED [AMERISOURCE BERGEN]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKGOOD NEIGHBOR PHARMACY SINUS RELIEF (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) CAPSULE, COATED [AMERISOURCE BERGEN]2
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DGOOD NEIGHBOR PHARMACY SINUS RELIEF (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) CAPSULE, COATED [AMERISOURCE BERGEN]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGOOD NEIGHBOR PHARMACY SINUS RELIEF (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) CAPSULE, COATED [AMERISOURCE BERGEN]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990GOOD NEIGHBOR PHARMACY SINUS RELIEF (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) CAPSULE, COATED [AMERISOURCE BERGEN]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EGOOD NEIGHBOR PHARMACY SINUS RELIEF (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) CAPSULE, COATED [AMERISOURCE BERGEN]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GOOD NEIGHBOR PHARMACY SINUS RELIEF (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) CAPSULE, COATED [AMERISOURCE BERGEN]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APGOOD NEIGHBOR PHARMACY SINUS RELIEF (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) CAPSULE, COATED [AMERISOURCE BERGEN]2
TALCINACTIVE INGREDIENT7SEV7J4R1UGOOD NEIGHBOR PHARMACY SINUS RELIEF (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) CAPSULE, COATED [AMERISOURCE BERGEN]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGOOD NEIGHBOR PHARMACY SINUS RELIEF (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) CAPSULE, COATED [AMERISOURCE BERGEN]2