rx act cold and allergy

Product NDC
37808-906
11-digit product format
378080906
Labeler code
37808
Product ID
37808-906_6fe4441a-5e2c-4c39-b379-3b2478547a68
Type
HUMAN OTC DRUG
Nonproprietary name
phenylephrine hcl, brompheniramine maleate
Dosage form
SOLUTION
Route
ORAL
Labeler
H E B
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2006-10-16
Marketing end
0000-00-00
Substance
PHENYLEPHRINE HYDROCHLORIDE; BROMPHENIRAMINE MALEATE
Active strength
3 mg/5mL; mg/5mL
NDC exclude flag
No
Listing certified through
2019-12-31
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 productproduct37808-906DDiscontinued by firm2026-10-15
excluded packagepackage37808-90637808-906-26DDiscontinued by firm2026-10-15

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 packagepackage37808-906-26d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage37808-906-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage37808-906-262ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage37808-906-26a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage37808-906-26cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage37808-906-26cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage37808-906-26302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage37808-906-26ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage37808-906-260efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage37808-906-26ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage37808-906-26367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage37808-906-26557ba5c1ecfa…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
BROMPHENIRAMINE MALEATEACTIVE INGREDIENTIXA7C9ZN03RX ACT COLD AND ALLERGY CHILDRENS (PHENYLEPHRINE HCL, BROMPHENIRAMINE MALEATE) LIQUID [H E B]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJRX ACT COLD AND ALLERGY CHILDRENS (PHENYLEPHRINE HCL, BROMPHENIRAMINE MALEATE) LIQUID [H E B]2
BROMPHENIRAMINEACTIVE MOIETYH57G17P2FNRX ACT COLD AND ALLERGY CHILDRENS (PHENYLEPHRINE HCL, BROMPHENIRAMINE MALEATE) LIQUID [H E B]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVRX ACT COLD AND ALLERGY CHILDRENS (PHENYLEPHRINE HCL, BROMPHENIRAMINE MALEATE) LIQUID [H E B]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLRX ACT COLD AND ALLERGY CHILDRENS (PHENYLEPHRINE HCL, BROMPHENIRAMINE MALEATE) LIQUID [H E B]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KRX ACT COLD AND ALLERGY CHILDRENS (PHENYLEPHRINE HCL, BROMPHENIRAMINE MALEATE) LIQUID [H E B]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDRX ACT COLD AND ALLERGY CHILDRENS (PHENYLEPHRINE HCL, BROMPHENIRAMINE MALEATE) LIQUID [H E B]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOARX ACT COLD AND ALLERGY CHILDRENS (PHENYLEPHRINE HCL, BROMPHENIRAMINE MALEATE) LIQUID [H E B]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXRX ACT COLD AND ALLERGY CHILDRENS (PHENYLEPHRINE HCL, BROMPHENIRAMINE MALEATE) LIQUID [H E B]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3RX ACT COLD AND ALLERGY CHILDRENS (PHENYLEPHRINE HCL, BROMPHENIRAMINE MALEATE) LIQUID [H E B]2
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYRX ACT COLD AND ALLERGY CHILDRENS (PHENYLEPHRINE HCL, BROMPHENIRAMINE MALEATE) LIQUID [H E B]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EURX ACT COLD AND ALLERGY CHILDRENS (PHENYLEPHRINE HCL, BROMPHENIRAMINE MALEATE) LIQUID [H E B]2
SORBITOLINACTIVE INGREDIENT506T60A25RRX ACT COLD AND ALLERGY CHILDRENS (PHENYLEPHRINE HCL, BROMPHENIRAMINE MALEATE) LIQUID [H E B]2
WATERINACTIVE INGREDIENT059QF0KO0RRX ACT COLD AND ALLERGY CHILDRENS (PHENYLEPHRINE HCL, BROMPHENIRAMINE MALEATE) LIQUID [H E B]2