Day Time Cold/Flu Relief

Product NDC
67510-0544
11-digit product format
675100544
Labeler code
67510
Product ID
67510-0544_f32e3302-f170-4be8-a351-8b383d43052d
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan, Phenylephrine
Dosage form
LIQUID
Route
ORAL
Labeler
Kareway Product, Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-09-06
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325 mg/15mL; mg/15mL; mg/15mL
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67510-0544IInactivated by FDA2026-10-21
excluded packagepackage67510-054467510-0544-0IInactivated by FDA2026-10-21
excluded packagepackage67510-054467510-0544-2IInactivated by FDA2026-10-21
excluded packagepackage67510-054467510-0544-4IInactivated by FDA2026-10-21
excluded packagepackage67510-054467510-0544-6IInactivated by FDA2026-10-21

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 2 · 110 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 packagepackage67510-0544-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67510-0544-0d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67510-0544-4d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67510-0544-6d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67510-0544-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67510-0544-0f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67510-0544-4f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67510-0544-6f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67510-0544-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67510-0544-02ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67510-0544-42ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67510-0544-62ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67510-0544-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67510-0544-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67510-0544-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67510-0544-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67510-0544-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67510-0544-0cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67510-0544-4cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67510-0544-6cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67510-0544-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67510-0544-0cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67510-0544-4cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67510-0544-6cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67510-0544-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67510-0544-0302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67510-0544-4302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67510-0544-6302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67510-0544-2ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67510-0544-0ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67510-0544-4ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67510-0544-6ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67510-0544-20efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67510-0544-00efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67510-0544-40efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67510-0544-60efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67510-0544-2ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67510-0544-0ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67510-0544-4ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67510-0544-6ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67510-0544-2367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67510-0544-0367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67510-0544-4367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67510-0544-6367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67510-0544-2557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67510-0544-0557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67510-0544-4557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67510-0544-6557ba5c1ecfa…9c80585c8c6e…

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
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
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0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
377068df-225f-7318-a910-a1987cdfa361Product name320170608
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
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23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
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cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
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d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67510-0544-0Day Time Cold/Flu Relief295 mL in 1 BOTTLELIQUID2953
67510-0544-2Day Time Cold/Flu Relief354 mL in 1 BOTTLELIQUID3543
67510-0544-4Day Time Cold/Flu Relief120 mL in 1 BOTTLELIQUID1203
67510-0544-6Day Time Cold/Flu Relief177 mL in 1 BOTTLELIQUID1773

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DDAY TIME COLD/FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) LIQUID [KAREWAY PRODUCT, INC.]3
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHDAY TIME COLD/FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) LIQUID [KAREWAY PRODUCT, INC.]3
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJDAY TIME COLD/FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) LIQUID [KAREWAY PRODUCT, INC.]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DDAY TIME COLD/FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) LIQUID [KAREWAY PRODUCT, INC.]3
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSDAY TIME COLD/FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) LIQUID [KAREWAY PRODUCT, INC.]3
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVDAY TIME COLD/FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) LIQUID [KAREWAY PRODUCT, INC.]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPDAY TIME COLD/FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) LIQUID [KAREWAY PRODUCT, INC.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADAY TIME COLD/FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) LIQUID [KAREWAY PRODUCT, INC.]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDAY TIME COLD/FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) LIQUID [KAREWAY PRODUCT, INC.]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADAY TIME COLD/FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) LIQUID [KAREWAY PRODUCT, INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DAY TIME COLD/FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) LIQUID [KAREWAY PRODUCT, INC.]3
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYDAY TIME COLD/FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) LIQUID [KAREWAY PRODUCT, INC.]3
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRDAY TIME COLD/FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) LIQUID [KAREWAY PRODUCT, INC.]3
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4DAY TIME COLD/FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) LIQUID [KAREWAY PRODUCT, INC.]3
SUCROSEINACTIVE INGREDIENTC151H8M554DAY TIME COLD/FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) LIQUID [KAREWAY PRODUCT, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RDAY TIME COLD/FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) LIQUID [KAREWAY PRODUCT, INC.]3
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEDAY TIME COLD/FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) LIQUID [KAREWAY PRODUCT, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67510-0544DAY TIME COLD/FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) LIQUID [KAREWAY PRODUCT, INC.]3Legacy NDC, 4 package rows20120713_28880f80-5d05-40a7-aaf0-0563c6f68c3a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1113705acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral SolutionPSN28880f80-5d05-40a7-aaf0-0563c6f68c3a3
1113705acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCD28880f80-5d05-40a7-aaf0-0563c6f68c3a3
1113705acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral SolutionSY28880f80-5d05-40a7-aaf0-0563c6f68c3a3
1113705acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral SolutionSY28880f80-5d05-40a7-aaf0-0563c6f68c3a3
1113705APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSY28880f80-5d05-40a7-aaf0-0563c6f68c3a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
67510-0544-067510054400295 mL in 1 BOTTLE295 mlHistorical
67510-0544-267510054402354 mL in 1 BOTTLE354 mlHistorical
67510-0544-467510054404120 mL in 1 BOTTLE120 mlHistorical
67510-0544-667510054406177 mL in 1 BOTTLE177 mlHistorical