FDA.reportPublic FDA data

Sinus plus Headache

Product NDC
63868-582
11-digit product format
638680582
Labeler code
63868
Product ID
63868-582_284ab23b-d845-11be-e063-6394a90aecb3
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE
Dosage form
TABLET, COATED
Route
ORAL
Labeler
CHAIN DRUG MARKETING ASSOCIATION INC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-06-15
Substance
ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 5 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], 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
Sinus plus Headache
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 04JA59TNSJ
Rxcui1046378

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-582-24Sinus plus Headache2 in 1 CARTONTABLET, COATED24
63868-582-24Sinus plus Headache12 in 1 BLISTER PACKTABLET, COATED124

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-582-24EA - Each63868-58208b34b24-298a-4e0c-b33b-48d7029dabda12022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-582SINUS PLUS HEADACHE (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION INC]4Current NDC, Legacy NDC, 2 package rows20241204_fe0cf681-f42c-430c-8429-f7ba4bc5a976.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046378acetaminophen 325 MG / phenylephrine HCl 5 MG Oral TabletPSNfe0cf681-f42c-430c-8429-f7ba4bc5a9764
1046378acetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDfe0cf681-f42c-430c-8429-f7ba4bc5a9764
1046378APAP 325 MG / phenylephrine hydrochloride 5 MG Oral TabletSYfe0cf681-f42c-430c-8429-f7ba4bc5a9764

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-582-24638680582242 BLISTER PACK in 1 CARTON (63868-582-24) / 12 TABLET, COATED in 1 BLISTER PACK2 blister pack2020-06-150000-00-00NoNoCurrent