Home NDC 47682-162 Dover Sudanyl PE
Product NDC 47682-162
11-digit product format 476820162
Labeler code 47682
Product ID 47682-162_3e4c212c-9fa3-9a39-e063-6294a90a7f2e
Type HUMAN OTC DRUG
Nonproprietary name PHENYLEPHRINE HYDROCHLORIDE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Unifirst First Aid Corporation
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2008-12-30
Marketing end 2027-08-31
Substance PHENYLEPHRINE HYDROCHLORIDE
Active strength 5 mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag No
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Dover Sudanyl PE Active Ingredients# Ingredient, Strength table Ingredient Strength PHENYLEPHRINE HYDROCHLORIDE 5 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii 04JA59TNSJ Rxcui 1299145
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 47682-162-13 Dover Sudanyl PE 500 in 1 BOX TABLET, FILM COATED 500 13 47682-162-99 Dover Sudanyl PE 2 in 1 PACKET TABLET, FILM COATED 2 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ MEDIQUE MEDI-PHENYL (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED DOVER SUDANYL PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION] 2 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV MEDIQUE MEDI-PHENYL (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED DOVER SUDANYL PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MEDIQUE MEDI-PHENYL (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED DOVER SUDANYL PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 MEDIQUE MEDI-PHENYL (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED DOVER SUDANYL PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA MEDIQUE MEDI-PHENYL (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED DOVER SUDANYL PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 MEDIQUE MEDI-PHENYL (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED DOVER SUDANYL PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO MEDIQUE MEDI-PHENYL (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED DOVER SUDANYL PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION] 2 LACTOSE INACTIVE INGREDIENT J2B2A4N98G MEDIQUE MEDI-PHENYL (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED DOVER SUDANYL PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MEDIQUE MEDI-PHENYL (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED DOVER SUDANYL PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION] 2 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A MEDIQUE MEDI-PHENYL (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED DOVER SUDANYL PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A MEDIQUE MEDI-PHENYL (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED DOVER SUDANYL PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 MEDIQUE MEDI-PHENYL (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED DOVER SUDANYL PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MEDIQUE MEDI-PHENYL (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED DOVER SUDANYL PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MEDIQUE MEDI-PHENYL (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED DOVER SUDANYL PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 47682-162 MEDIQUE MEDI-PHENYL (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED DOVER SUDANYL PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION] 12 Current NDC, Legacy NDC, 2 package rows 20241226_d7d62ac1-1333-4366-884b-26537766ce38.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 47682-162-13 47682016213 500 PACKET in 1 BOX (47682-162-13) / 2 TABLET, FILM COATED in 1 PACKET (47682-162-99) 500 packet 2008-12-30 2027-08-31 No No Current 47682-162-99 47682016299 2 TABLET, FILM COATED in 1 PACKET (47682-162-99) 2008-12-30 2027-08-31 No No Current