FDA.reportPublic FDA data

Antiflu Des

Product NDC
82688-001
11-digit product format
826880001
Labeler code
82688
Product ID
82688-001_24b33596-d38f-be47-e063-6394a90ab641
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen Phenylephrine HCl Chlorpheniramine Maleate
Dosage form
CAPSULE
Route
ORAL
Labeler
Productos Farmaceuticos, S.A. de C.V.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-04-15
Substance
ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 4; 10 mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Antiflu Des
Brand name suffix
Cough and Flu
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
CHLORPHENIRAMINE MALEATE4 mg/1
PHENYLEPHRINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, V1Q0O9OJ9Z, 04JA59TNSJ
Rxcui2599517

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82688-001-12Antiflu DesCough and Flu1 in 1 CARTONCAPSULE12
82688-001-12Antiflu DesCough and Flu12 in 1 BLISTER PACKCAPSULE122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82688-001ANTIFLU DES COUGH AND FLU (ACETAMINOPHEN PHENYLEPHRINE HCL CHLORPHENIRAMINE MALEATE) CAPSULE [PRODUCTOS FARMACEUTICOS, S.A. DE C.V.]2Current NDC, Legacy NDC, 2 package rows20241019_dcf3897a-a793-6df7-e053-2995a90a25f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2599517acetaminophen 325 MG / chlorpheniramine maleate 4 MG / phenylephrine HCl 10 MG Oral CapsulePSNdcf3897a-a793-6df7-e053-2995a90a25f82
2599517acetaminophen 325 MG / chlorpheniramine maleate 4 MG / phenylephrine hydrochloride 10 MG Oral CapsuleSCDdcf3897a-a793-6df7-e053-2995a90a25f82
2599517APAP 325 MG / chlorpheniramine maleate 4 MG / phenylephrine hydrochloride 10 MG Oral CapsuleSYdcf3897a-a793-6df7-e053-2995a90a25f82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82688-001-12826880001121 BLISTER PACK in 1 CARTON (82688-001-12) / 12 CAPSULE in 1 BLISTER PACK1 blister pack2022-04-150000-00-00NoNoCurrent