Cold Relief

Product NDC
63981-701
11-digit product format
639810701
Labeler code
63981
Product ID
63981-701_49ae28ef-389b-4e62-b3b4-8f2e1d6c75d8
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl
Dosage form
KIT
Labeler
COSTCO WHOLESALE CORPORATION
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2005-07-21
Marketing end
2020-06-16
Active strength
0
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63981-701DDiscontinued by firm2026-10-12
excluded packagepackage63981-70163981-701-81DDiscontinued 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 packagepackage63981-701-81d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63981-701-81f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63981-701-812ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63981-701-81a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63981-701-81cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63981-701-81cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63981-701-81302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63981-701-81ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63981-701-810efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63981-701-81ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63981-701-81367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63981-701-81557ba5c1ecfa…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 RELIEF (ACETAMINOPHEN, CHLORPEHNIRAMINE HCL, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) KIT [COSTCO WHOLESALE CORPORATION]3
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZMULTI-SYMPTOM COLD RELIEF (ACETAMINOPHEN, CHLORPEHNIRAMINE HCL, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) KIT [COSTCO WHOLESALE CORPORATION]3
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHMULTI-SYMPTOM COLD RELIEF (ACETAMINOPHEN, CHLORPEHNIRAMINE HCL, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) KIT [COSTCO WHOLESALE CORPORATION]3
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJMULTI-SYMPTOM COLD RELIEF (ACETAMINOPHEN, CHLORPEHNIRAMINE HCL, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) KIT [COSTCO WHOLESALE CORPORATION]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DMULTI-SYMPTOM COLD RELIEF (ACETAMINOPHEN, CHLORPEHNIRAMINE HCL, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) KIT [COSTCO WHOLESALE CORPORATION]3
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965UMULTI-SYMPTOM COLD RELIEF (ACETAMINOPHEN, CHLORPEHNIRAMINE HCL, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) KIT [COSTCO WHOLESALE CORPORATION]3
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSMULTI-SYMPTOM COLD RELIEF (ACETAMINOPHEN, CHLORPEHNIRAMINE HCL, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) KIT [COSTCO WHOLESALE CORPORATION]3
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVMULTI-SYMPTOM COLD RELIEF (ACETAMINOPHEN, CHLORPEHNIRAMINE HCL, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) KIT [COSTCO WHOLESALE CORPORATION]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMULTI-SYMPTOM COLD RELIEF (ACETAMINOPHEN, CHLORPEHNIRAMINE HCL, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) KIT [COSTCO WHOLESALE CORPORATION]3
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990MULTI-SYMPTOM COLD RELIEF (ACETAMINOPHEN, CHLORPEHNIRAMINE HCL, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) KIT [COSTCO WHOLESALE CORPORATION]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMULTI-SYMPTOM COLD RELIEF (ACETAMINOPHEN, CHLORPEHNIRAMINE HCL, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) KIT [COSTCO WHOLESALE CORPORATION]3