FDA.reportPublic FDA data

sinus

Product NDC
30142-613
11-digit product format
301420613
Labeler code
30142
Product ID
30142-613_dd93ccf7-3c7a-46b7-a59b-b513eec4dc68
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudoephedrine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Kroger Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-09-18
Substance
PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
30 mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage30142-61330142-613-62DDiscontinued by firm2026-10-20
excluded packagepackage30142-61330142-613-67DDiscontinued by firm2026-10-20

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0530142-613-62d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0530142-613-67d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2630142-613-62f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2630142-613-67f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3130142-613-622ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3130142-613-672ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2830142-613-62a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2830142-613-67a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2130142-613-62cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2130142-613-67cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1030142-613-62cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1030142-613-67cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3130142-613-62302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3130142-613-67302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2030142-613-62ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2030142-613-67ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1030142-613-620efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1030142-613-670efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0830142-613-62ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0830142-613-67ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0330142-613-62367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0330142-613-67367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0930142-613-62557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0930142-613-67557ba5c1ecfa…9c80585c8c6e…

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
sinus
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PSEUDOEPHEDRINE HYDROCHLORIDE30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6V9V2RYJ8NInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049160Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
18812f2a-9b66-45a7-9631-123da6fd1c1fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30142-613-62sinus1 in 1 BLISTER PACKTABLET, FILM COATED14
30142-613-62sinus24 in 1 CARTONTABLET, FILM COATED244
30142-613-67sinus48 in 1 CARTONTABLET, FILM COATED484
30142-613-67sinus1 in 1 BLISTER PACKTABLET, FILM COATED14
30142-613-80sinus96 in 1 CARTONTABLET, FILM COATED964
30142-613-80sinus1 in 1 BLISTER PACKTABLET, FILM COATED14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-613SINUS (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [KROGER COMPANY]4Current NDC, Legacy NDC, 6 package rows20240922_18812f2a-9b66-45a7-9631-123da6fd1c1f.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 80 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
cherry throat relief lozengesBENZOCAINECintas Corporation49b25e9e-1d47-4a10-e054-00144ff8d46c2025-12-07WarningsExact identifier
application number: M012
cherry sore throat lozengeBENZOCAINECVS Pharmacy3c54974d-9d15-2fa1-e054-00144ff88e882025-12-07WarningsExact identifier
application number: M012
honey lemon sore throat lozengesBENZOCAINECVS Pharmacy3c55009c-4b3e-135e-e054-00144ff8d46c2025-12-07WarningsExact identifier
application number: M012
sugar free menthol cough dropsMENTHOLCVS Pharmacy3bdd24a8-3b44-00cd-e054-00144ff8d46c2025-12-07WarningsExact identifier
application number: M012
sugar free honey lemon cough dropsMENTHOLCVS Pharmacy3c125b3a-e58f-5c06-e054-00144ff88e882025-12-07WarningsExact identifier
application number: M012
CVS Menthol Cough DropsMENTHOLCVS Pharmacyde97d13b-bb67-d0e6-e053-2995a90aeb2c2025-12-07WarningsExact identifier
application number: M012
menthol cough dropsMENTHOLAmerican Sales34dd34d1-1a08-3470-e054-00144ff8d46c2025-12-06WarningsExact identifier
application number: M012
DOLOGENACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATEKramer Novis656ea9ba-c9cf-44c6-af40-b8ba292ce38a2025-12-05WarningsExact identifier
application number: M012
Afrin No Drip Severe CongestionOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLCa79b5541-864b-412a-a085-96986ed6af592025-12-05WarningsExact identifier
application number: M012
Afrin No Drip Extra MoisturizingOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.346f32cb-74cb-4896-b770-76d5f829a17d2025-12-05WarningsExact identifier
application number: M012
Afrin No Drip Original Pump MistOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.530b2d27-5883-489e-87fa-90b45eb93b3c2025-12-05WarningsExact identifier
application number: M012
Coricidin HBP Cough and Cold Cough Suppressant, AntihistamineCHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.ee666963-e686-4374-b52b-a677f1cd41142025-12-05WarningsExact identifier
application number: M012
Afrin No-Drip Allergy SinusOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC3beb5839-7422-449d-e054-00144ff88e882025-12-05WarningsExact identifier
application number: M012
Coricidin HBP Nighttime Multi-Symptom ColdACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.513ca24f-1262-4a2d-e054-00144ff8d46c2025-12-05WarningsExact identifier
application number: M012
Afrin Severe CongestionOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.a49a506e-aca2-4af0-a50b-dca2c031e61d2025-12-05WarningsExact identifier
application number: M012
Throat Coat Sweet Orange FennelMENTHOLTraditional Medicinals, Inc.a746cef4-1fb4-45cf-e053-2995a90a02c82025-12-05WarningsExact identifier
application number: M012
GuaifenesinGUAIFENESINHealth Pharma USA LLC31755594-3e1c-b290-e063-6394a90aba612025-12-05WarningsExact identifier
application number: M012
Tabcin Extra StrengthACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL,Pharmadel LLC0670c33e-8a3c-ae00-e063-6294a90a165b2025-12-05WarningsExact identifier
application number: M012
Severe Sinus Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINEShield Pharmaceuticals Corpd0dd4a75-da65-4c66-b65f-54ee141008462025-12-05WarningsExact identifier
application number: M012
Basic Care Cherry Cough DropsMENTHOLAmazon.comc0588221-0c84-66d8-e053-2995a90a874f2025-12-05WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049160pseudoephedrine HCl 30 MG Oral TabletPSN18812f2a-9b66-45a7-9631-123da6fd1c1f4
1049160pseudoephedrine hydrochloride 30 MG Oral TabletSCD18812f2a-9b66-45a7-9631-123da6fd1c1f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-613-623014206136224 BLISTER PACK in 1 CARTON (30142-613-62) > 1 TABLET, FILM COATED in 1 BLISTER PACK24 blister pack2020-09-180000-00-00NoNoCurrent
30142-613-673014206136748 BLISTER PACK in 1 CARTON (30142-613-67) > 1 TABLET, FILM COATED in 1 BLISTER PACK48 blister pack2020-09-180000-00-00NoNoCurrent
30142-613-803014206138096 BLISTER PACK in 1 CARTON (30142-613-80) / 1 TABLET, FILM COATED in 1 BLISTER PACK96 blister pack2020-09-180000-00-00NoNoCurrent