Congestion Relief

Product NDC
37808-158
11-digit product format
378080158
Labeler code
37808
Product ID
37808-158_7d88c73b-b8ae-44e3-b1dd-a6e5cd4b4009
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen, phenylephrine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
H E B
Application
ANDA203200
Marketing category
ANDA
Marketing start
2016-04-18
Substance
IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
200; 10 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [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
Congestion Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1
PHENYLEPHRINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM, 04JA59TNSJ
Rxcui1369775

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-158-60Congestion Relief1 in 1 BLISTER PACKTABLET, FILM COATED13
37808-158-60Congestion Relief20 in 1 CARTONTABLET, FILM COATED203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-158CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [H E B]3Current NDC, Legacy NDC, 2 package rows20191206_8e46fe47-e429-4b0c-ae4a-9b8e5e6a5036.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1369775ibuprofen 200 MG / phenylephrine HCl 10 MG Oral TabletPSN8e46fe47-e429-4b0c-ae4a-9b8e5e6a50363
1369775ibuprofen 200 MG / phenylephrine hydrochloride 10 MG Oral TabletSCD8e46fe47-e429-4b0c-ae4a-9b8e5e6a50363

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-158-603780801586020 BLISTER PACK in 1 CARTON (37808-158-60) / 1 TABLET, FILM COATED in 1 BLISTER PACK20 blister pack2016-04-180000-00-00NoNoCurrent