hybrid CF

Product NDC
49804-101
11-digit product format
498040101
Labeler code
49804
Product ID
49804-101_5e3e64e8-adb5-4072-a226-732d7ca75f57
Type
HUMAN OTC DRUG
Nonproprietary name
APAP 500 mg Phenylephrine HCL 5 mg Chlorpheniramine maleate 2 mg
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Hybrid-Rx LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2010-02-03
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE
Active strength
500 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct49804-101IInactivated by FDA2026-10-05
excluded packagepackage49804-10149804-101-24IInactivated 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 1 · 44 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 packagepackage49804-101-24d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49804-101-24f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49804-101-242ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49804-101-24a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49804-101-24cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49804-101-24cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49804-101-24302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49804-101-24ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49804-101-240efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49804-101-24ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49804-101-24367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49804-101-24557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage49804-101-248af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage49804-101-24834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage49804-101-241332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage49804-101-24fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage49804-101-2486f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage49804-101-24bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage49804-101-248dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage49804-101-24e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage49804-101-249bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage49804-101-24110d247fa046…a55b01930146…

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
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49804-101-242019-10-21C16284748780-1956f9ecf-d755-621f-e053-dbdaa90a74adDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49804-101-24hybrid CF1 in 1 CARTONTABLET, FILM COATED11
49804-101-24hybrid CF12 in 1 BLISTER PACKTABLET, FILM COATED121

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYBRID CF (APAP 500 MG PHENYLEPHRINE HCL 5 MG CHLORPHENIRAMINE MALEATE 2 MG) TABLET, FILM COATED [HYBRID-RX LLC]1
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZHYBRID CF (APAP 500 MG PHENYLEPHRINE HCL 5 MG CHLORPHENIRAMINE MALEATE 2 MG) TABLET, FILM COATED [HYBRID-RX LLC]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJHYBRID CF (APAP 500 MG PHENYLEPHRINE HCL 5 MG CHLORPHENIRAMINE MALEATE 2 MG) TABLET, FILM COATED [HYBRID-RX LLC]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYBRID CF (APAP 500 MG PHENYLEPHRINE HCL 5 MG CHLORPHENIRAMINE MALEATE 2 MG) TABLET, FILM COATED [HYBRID-RX LLC]1
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965UHYBRID CF (APAP 500 MG PHENYLEPHRINE HCL 5 MG CHLORPHENIRAMINE MALEATE 2 MG) TABLET, FILM COATED [HYBRID-RX LLC]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVHYBRID CF (APAP 500 MG PHENYLEPHRINE HCL 5 MG CHLORPHENIRAMINE MALEATE 2 MG) TABLET, FILM COATED [HYBRID-RX LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYBRID CF (APAP 500 MG PHENYLEPHRINE HCL 5 MG CHLORPHENIRAMINE MALEATE 2 MG) TABLET, FILM COATED [HYBRID-RX LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYBRID CF (APAP 500 MG PHENYLEPHRINE HCL 5 MG CHLORPHENIRAMINE MALEATE 2 MG) TABLET, FILM COATED [HYBRID-RX LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYBRID CF (APAP 500 MG PHENYLEPHRINE HCL 5 MG CHLORPHENIRAMINE MALEATE 2 MG) TABLET, FILM COATED [HYBRID-RX LLC]1
HYPROMELLOSE 2910 (15 CPS)INACTIVE INGREDIENT36SFW2JZ0WHYBRID CF (APAP 500 MG PHENYLEPHRINE HCL 5 MG CHLORPHENIRAMINE MALEATE 2 MG) TABLET, FILM COATED [HYBRID-RX LLC]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EHYBRID CF (APAP 500 MG PHENYLEPHRINE HCL 5 MG CHLORPHENIRAMINE MALEATE 2 MG) TABLET, FILM COATED [HYBRID-RX LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYBRID CF (APAP 500 MG PHENYLEPHRINE HCL 5 MG CHLORPHENIRAMINE MALEATE 2 MG) TABLET, FILM COATED [HYBRID-RX LLC]1
TRIACETININACTIVE INGREDIENTXHX3C3X673HYBRID CF (APAP 500 MG PHENYLEPHRINE HCL 5 MG CHLORPHENIRAMINE MALEATE 2 MG) TABLET, FILM COATED [HYBRID-RX LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49804-101HYBRID CF (APAP 500 MG PHENYLEPHRINE HCL 5 MG CHLORPHENIRAMINE MALEATE 2 MG) TABLET, FILM COATED [HYBRID-RX LLC]1Legacy NDC, 2 package rows20100209_f501f971-4712-43bc-aee7-a244d24488fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1052679acetaminophen 500 MG / chlorpheniramine maleate 2 MG / phenylephrine HCl 5 MG Oral TabletPSNf501f971-4712-43bc-aee7-a244d24488fb1
1052679acetaminophen 500 MG / chlorpheniramine maleate 2 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDf501f971-4712-43bc-aee7-a244d24488fb1
1052679APAP 500 MG / Chlorpheniramine Maleate 2 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSYf501f971-4712-43bc-aee7-a244d24488fb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
49804-101-24498040101241 in 1 CARTONHistorical