FDA.reportPublic FDA data

Nasal Decongestant PE

Product NDC
70677-1152
11-digit product format
706771152
Labeler code
70677
Product ID
70677-1152_611ee94e-9812-4470-b594-eecd8f7efb7a
Type
HUMAN OTC DRUG
Nonproprietary name
Phenylephrine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-04-05
Substance
PHENYLEPHRINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Nasal Decongestant PE
Brand name suffix
Maximum Strength
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049182Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8460d4f9-8d7b-4ae4-8047-c2010d9c8013Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
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
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-1152-1Nasal Decongestant PEMaximum Strength1 in 1 CARTONTABLET, FILM COATED17
70677-1152-1Nasal Decongestant PEMaximum Strength18 in 1 BLISTER PACKTABLET, FILM COATED187
70677-1152-2Nasal Decongestant PEMaximum Strength2 in 1 CARTONTABLET, FILM COATED27
70677-1152-2Nasal Decongestant PEMaximum Strength18 in 1 BLISTER PACKTABLET, FILM COATED187

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1152-1EA - Each70677-11527db53ae9-73e8-4349-91d8-5d28fd49616d12023-09-05
70677-1152-2EA - Each70677-11529866d1bb-b8bc-4c68-8c2b-dd5a4c8acf8112023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1152NASAL DECONGESTANT PE MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [STRATEGIC SOURCING SERVICES LLC]6Current NDC, 4 package rows20250428_8460d4f9-8d7b-4ae4-8047-c2010d9c8013.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 73 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
QUALITY CHOICE Cough Drops Black Cherry SUGAR FREEMENTHOLChain Drug Marketing Association, Inc.8f6ee01c-baad-489f-b2fd-0ef506916ee42025-12-18WarningsExact identifier
application number: M012
menthol cough dropsMENTHOLMeijer5baeaff7-172c-187a-e053-2a91aa0ab1652025-12-18WarningsExact identifier
application number: M012
Menthol Cough DropsMENTHOLMeijer Distribution Inc.3bee752a-4141-1f5b-e054-00144ff8d46c2025-12-18WarningsExact identifier
application number: M012
cherry cough dropsMENTHOLMeijer5bc2ec81-a3cb-3a59-e053-2a91aa0ac14e2025-12-18WarningsExact identifier
application number: M012
cherry cough dropsMENTHOLMeijer5bc3b9b8-e61e-1041-e053-2a91aa0a3d832025-12-18WarningsExact identifier
application number: M012
honey lemon cough dropsMENTHOLMeijer5bd35bce-cd85-5314-e053-2991aa0abce62025-12-18WarningsExact identifier
application number: M012
honey lemon cough dropsMENTHOLMeijer5bd42654-56e5-997e-e053-2a91aa0afd342025-12-18WarningsExact identifier
application number: M012
sugar free menthol cough dropsMENTHOLMeijer5bd61cd4-a5ca-9d66-e053-2a91aa0a93a32025-12-18WarningsExact identifier
application number: M012
sugar free honey lemon cough dropsMENTHOLMeijer5bd7c24d-6a61-5d2d-e053-2a91aa0a08ed2025-12-18WarningsExact identifier
application number: M012
SF Honey Lemon Cough DropsMENTHOLMeijer Distribution70e3de9a-1804-ef15-e053-2a95a90a33402025-12-18WarningsExact identifier
application number: M012
QUALITY CHOICE Cough Drops Vanilla HoneyMENTHOLChain Drug Marketing Association, Inc.3d6a4bcc-1044-40f5-928a-378ececcb6872025-12-18WarningsExact identifier
application number: M012
Meijer Strawberry Cough DropsMENTHOLMeijer164de637-e644-711c-e063-6294a90a1c5f2025-12-18WarningsExact identifier
application number: M012
Meijer Severe Menthol Throat DropsMENTHOLMeijer16603ca4-1ce5-2e7e-e063-6394a90ad6f12025-12-18WarningsExact identifier
application number: M012
Allergy Relief ChildrensDIPHENHYDRAMINE HCLA-S Medication Solutions60587987-c303-4617-ba96-c518ab2a06502025-12-18WarningsExact identifier
application number: M012
NiafluDEXTROMETHORPHAN HBR, GUAIFENESINPharmadel LLC399898f0-e40a-4f5d-e063-6294a90a667d2025-12-17WarningsExact identifier
application number: M012
Cherry cough dropMENTHOLThe Kroget Co.4313a6ce-454d-4c4b-e054-00144ff88e882025-12-17WarningsExact identifier
application number: M012
Menthol cough dropMENTHOLThe Kroger Co.42b257e9-f45e-32c9-e054-00144ff8d46c2025-12-17WarningsExact identifier
application number: M012
Honey Lemon cough dropMENTHOLThe Kroger Co.4318f25a-05d9-2208-e054-00144ff88e882025-12-17WarningsExact identifier
application number: M012
Honey Lemon cough dropMENTHOLThe Kroger Co.4317f952-a228-0281-e054-00144ff88e882025-12-17WarningsExact identifier
application number: M012
Honey Lemon Cough DropMENTHOLThe Kroger Co.4316df6e-3ae6-4ab5-e054-00144ff88e882025-12-17WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049182phenylephrine HCl 10 MG Oral TabletPSN8460d4f9-8d7b-4ae4-8047-c2010d9c80137
1049182phenylephrine hydrochloride 10 MG Oral TabletSCD8460d4f9-8d7b-4ae4-8047-c2010d9c80137
1049182phenylephrine HCl 10 MG Oral TabletPSN7f4e8d37-8c6b-4849-b86c-4335a0bcac1c1
1049182phenylephrine HCl 10 MG Oral TabletPSN9d030767-dfd6-48b4-9b17-4e20c23915f31
1049182phenylephrine hydrochloride 10 MG Oral TabletSCD7f4e8d37-8c6b-4849-b86c-4335a0bcac1c1
1049182phenylephrine hydrochloride 10 MG Oral TabletSCD9d030767-dfd6-48b4-9b17-4e20c23915f31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70677-1152-1706771152011 BLISTER PACK in 1 CARTON (70677-1152-1) / 18 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2023-04-05NoNoCurrent
70677-1152-2706771152022 BLISTER PACK in 1 CARTON (70677-1152-2) / 18 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2023-04-05NoNoCurrent