FDA.reportPublic FDA data

Day Time Gelcap

Product NDC
67510-0523
11-digit product format
675100523
Labeler code
67510
Product ID
67510-0523_57c0ea57-c0f3-48e1-a8bd-834047b7f839
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan, Phenylephrine
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Kareway Product, Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-06-01
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325 mg/1; mg/1; mg/1
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 productproduct67510-0523IInactivated by FDA2026-10-05
excluded packagepackage67510-052367510-0523-0IInactivated by FDA2026-10-05
excluded packagepackage67510-052367510-0523-1IInactivated by FDA2026-10-05
excluded packagepackage67510-052367510-0523-2IInactivated by FDA2026-10-05
excluded packagepackage67510-052367510-0523-4IInactivated 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 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 packagepackage67510-0523-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67510-0523-0d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67510-0523-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67510-0523-4d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67510-0523-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67510-0523-0f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67510-0523-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67510-0523-4f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67510-0523-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67510-0523-02ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67510-0523-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67510-0523-42ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67510-0523-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67510-0523-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67510-0523-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67510-0523-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67510-0523-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67510-0523-0cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67510-0523-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67510-0523-4cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67510-0523-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67510-0523-0cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67510-0523-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67510-0523-4cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67510-0523-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67510-0523-0302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67510-0523-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67510-0523-4302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67510-0523-2ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67510-0523-0ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67510-0523-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67510-0523-4ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67510-0523-20efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67510-0523-00efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67510-0523-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67510-0523-40efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67510-0523-2ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67510-0523-0ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67510-0523-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67510-0523-4ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67510-0523-2367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67510-0523-0367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67510-0523-1367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67510-0523-4367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67510-0523-2557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67510-0523-0557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67510-0523-1557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67510-0523-4557ba5c1ecfa…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
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
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
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
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
67510-0523-0Drug Facts
67510-0523-1Drug Facts
67510-0523-2Drug Facts
67510-0523-4Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67510-0523-0Day Time Gelcap20 in 1 BLISTER PACKCAPSULE, LIQUID FILLED201
67510-0523-0Day Time Gelcap2 in 1 BOXCAPSULE, LIQUID FILLED21
67510-0523-1Day Time Gelcap1 in 1 BOXCAPSULE, LIQUID FILLED11
67510-0523-1Day Time Gelcap10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED101
67510-0523-2Day Time Gelcap12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED121
67510-0523-2Day Time Gelcap1 in 1 BOXCAPSULE, LIQUID FILLED11
67510-0523-4Day Time Gelcap2 in 1 BOXCAPSULE, LIQUID FILLED21
67510-0523-4Day Time Gelcap24 in 1 BLISTER PACKCAPSULE, LIQUID FILLED241

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DDAY TIME GELCAP (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) CAPSULE, LIQUID FILLED [KAREWAY PRODUCT, INC.]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHDAY TIME GELCAP (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) CAPSULE, LIQUID FILLED [KAREWAY PRODUCT, INC.]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJDAY TIME GELCAP (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) CAPSULE, LIQUID FILLED [KAREWAY PRODUCT, INC.]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DDAY TIME GELCAP (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) CAPSULE, LIQUID FILLED [KAREWAY PRODUCT, INC.]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSDAY TIME GELCAP (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) CAPSULE, LIQUID FILLED [KAREWAY PRODUCT, INC.]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVDAY TIME GELCAP (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) CAPSULE, LIQUID FILLED [KAREWAY PRODUCT, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADAY TIME GELCAP (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) CAPSULE, LIQUID FILLED [KAREWAY PRODUCT, INC.]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MDAY TIME GELCAP (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) CAPSULE, LIQUID FILLED [KAREWAY PRODUCT, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LDAY TIME GELCAP (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) CAPSULE, LIQUID FILLED [KAREWAY PRODUCT, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDAY TIME GELCAP (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) CAPSULE, LIQUID FILLED [KAREWAY PRODUCT, INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ADAY TIME GELCAP (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) CAPSULE, LIQUID FILLED [KAREWAY PRODUCT, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EDAY TIME GELCAP (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) CAPSULE, LIQUID FILLED [KAREWAY PRODUCT, INC.]1
PROPYLENE GLYCOL, (R)-INACTIVE INGREDIENT602HN5L69HDAY TIME GELCAP (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) CAPSULE, LIQUID FILLED [KAREWAY PRODUCT, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RDAY TIME GELCAP (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) CAPSULE, LIQUID FILLED [KAREWAY PRODUCT, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RDAY TIME GELCAP (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) CAPSULE, LIQUID FILLED [KAREWAY PRODUCT, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67510-0523DAY TIME GELCAP (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) CAPSULE, LIQUID FILLED [KAREWAY PRODUCT, INC.]1Legacy NDC, 8 package rows20110616_4e73c368-e4eb-471e-aca4-fe551bde52bf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSN4e73c368-e4eb-471e-aca4-fe551bde52bf1
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD4e73c368-e4eb-471e-aca4-fe551bde52bf1
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSY4e73c368-e4eb-471e-aca4-fe551bde52bf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67510-0523-06751005230020 in 1 BLISTER PACKHistorical
67510-0523-1675100523011 in 1 BOXHistorical
67510-0523-26751005230212 in 1 BLISTER PACKHistorical
67510-0523-4675100523042 in 1 BOXHistorical