Nasal Decongestant

Product NDC
0536-3607
11-digit product format
005363607
Labeler code
0536
Product ID
0536-3607_0eafac67-d7aa-5b86-e063-6394a90a2184
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudoephedrine HCl
Dosage form
TABLET
Route
ORAL
Labeler
Rugby Laboratories
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-10-29
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nasal Decongestant
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
775f97c0-6f82-49a8-82ac-f1a73920c3ecAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-3607-35Nasal Decongestant24 in 1 BLISTER PACKTABLET245
0536-3607-35Nasal Decongestant1 in 1 CARTONTABLET15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-3607-35EA - Each0536-360742467ecb-1fff-4285-879d-82d9e9b9aa0e12013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NNASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [RUGBY LABORATORIES]1
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NNASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [PROFICIENT RX LP]1
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FNASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [PROFICIENT RX LP]1
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FNASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [RUGBY LABORATORIES]1
12-HYDROXYSTEARIC ACIDINACTIVE INGREDIENT933ANU3H2SNASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [PROFICIENT RX LP]1
12-HYDROXYSTEARIC ACIDINACTIVE INGREDIENT933ANU3H2SNASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [RUGBY LABORATORIES]1
ACER SACCHARUM POLLENINACTIVE INGREDIENTV38QUQ7861NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [RUGBY LABORATORIES]1
ACER SACCHARUM POLLENINACTIVE INGREDIENTV38QUQ7861NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [PROFICIENT RX LP]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKNASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [RUGBY LABORATORIES]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKNASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [PROFICIENT RX LP]1
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [RUGBY LABORATORIES]1
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [PROFICIENT RX LP]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZNASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [RUGBY LABORATORIES]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZNASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [RUGBY LABORATORIES]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [PROFICIENT RX LP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [PROFICIENT RX LP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [RUGBY LABORATORIES]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [RUGBY LABORATORIES]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [PROFICIENT RX LP]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [PROFICIENT RX LP]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [RUGBY LABORATORIES]1
GELATININACTIVE INGREDIENT2G86QN327LNASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [PROFICIENT RX LP]1
GELATININACTIVE INGREDIENT2G86QN327LNASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [RUGBY LABORATORIES]1
KAOLININACTIVE INGREDIENT24H4NWX5CONASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [PROFICIENT RX LP]1
KAOLININACTIVE INGREDIENT24H4NWX5CONASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [RUGBY LABORATORIES]1
MAGNESIUM SILICATEINACTIVE INGREDIENT9B9691B2N9NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [PROFICIENT RX LP]1
MAGNESIUM SILICATEINACTIVE INGREDIENT9B9691B2N9NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [RUGBY LABORATORIES]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [RUGBY LABORATORIES]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [PROFICIENT RX LP]1
SHELLACINACTIVE INGREDIENT46N107B71ONASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [PROFICIENT RX LP]1
SHELLACINACTIVE INGREDIENT46N107B71ONASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [RUGBY LABORATORIES]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [PROFICIENT RX LP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [RUGBY LABORATORIES]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [RUGBY LABORATORIES]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-3607NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [RUGBY LABORATORIES]5Current NDC, Legacy NDC, 2 package rows20240112_775f97c0-6f82-49a8-82ac-f1a73920c3ec.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 1 of 195 · 3,893 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCardinal Health 110, LLC. DBA Leader610accad-2f8b-4605-9357-a58e6e18d4172026-08-15WarningsExact identifier
application number: M012
CVS Childrens COLD PLUS COUGH PLUS SORE THROATACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDECVS PHARMACY27820bce-6638-4f17-ac66-62b02b76bec32026-08-14WarningsExact identifier
application number: M012
CVS PHARMACY Childrens Cold and AllergyBROMPHENIRAMINE MALEATECVS PHARMACY, INC.004e104b-d6ff-48d5-8685-cd1bff45399a2026-08-14WarningsExact identifier
application number: M012
CHILDRENS DIMETAPP COLD AND COUGHBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCVS PHARMACY7babf4f6-ca0a-44a7-b1ea-d60e20d36f152026-08-14WarningsExact identifier
application number: M012
CVS Mucus Relief DM and Overnight Cold and FluDEXTROMETHORPHAN HBR, GUAIFENESIN, ACETAMINOPHEN AND TRIPROLIDINE HCLCVS75520b77-d40b-4f43-b92a-7a3eba5b493f2026-08-14WarningsExact identifier
application number: M012
CVS Severe Multi-Symptom Cough Cold FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS PHARMACYbb24c298-1d00-4378-8de3-b4056220fa752026-08-14WarningsExact identifier
application number: M012
SEVERE COLD PLUS FLU DAYTIME NIGHTTIMEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATECVS Pharmacy,Inc.6cb1d08b-e544-4084-b9ed-1e0d99a709c82026-08-14Warnings, Adverse reactionsExact identifier
application number: M012
Theraflu Relief Max Strength DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBRCVS PHARMACY932a3d40-9b52-4e91-bc61-6fd506f2d9e62026-08-14WarningsExact identifier
application number: M012
Multi Symptom Severe Cold and Nighttime Severe Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLCVS Pharmacy,Inc.91063edd-1e7e-41e9-8412-b14ef37490182026-08-14WarningsExact identifier
application number: M012
CVS Childrens Cold and AllergyBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCLCVS PHARMACY, INC.f4020c08-29f6-4609-834e-191ce68851302026-08-14WarningsExact identifier
application number: M012
CVS Severe Cough, Flu Plus Sore Throat HoneyACETAMINOPHEN, DEXTROMETHORPHAN HBRCVS PHARMACY95203001-7ca6-4513-83a3-9ef17855bc0f2026-08-14WarningsExact identifier
application number: M012
Daytime Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCVS PHARMACY81d26e9c-b713-4fb3-b0a5-68526bad230e2026-08-14WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWalgreen Companye9d0b6f9-e9f3-431c-9f34-4d63108282a12026-08-13WarningsExact identifier
application number: M012
daytime nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCLAmazon.com Services LLC9bb6bbd5-508e-4781-ad1c-69ccf0a5f13e2026-08-13WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAmazon.com Services LLC1e3c81b0-05de-4c4a-8579-f301f14626b32026-08-13WarningsExact identifier
application number: M012
Tussin DM Daytime NighttimeDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDd59f6c64-8311-48ba-90d1-8000b04bfcda2026-08-13WarningsExact identifier
application number: M012
TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS DAY PLUS NIGHTACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEKenvue Brands LLC1c5578e6-7e67-c467-e063-6294a90a6e0b2026-08-12WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEAmazon.com Services LLCf95220c5-e55c-4271-a267-d004ad2447bf2026-08-12WarningsExact identifier
application number: M012
CVS PHARMACY Childrens Allergy ChewsDIPHENHYDRAMINE HCLCVS PHARMACY, INC.569b8efa-8458-49f7-a665-6b7016a105052026-08-12WarningsExact identifier
application number: M012
CVS PHARMACY DYE FREE Childrens Allergy ChewsDIPHENHYDRAMINE HCLCVS PHARMACY, INC.e6671e8b-653a-4f4e-b6f3-e31fcd14fbd72026-08-12WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049160pseudoephedrine HCl 30 MG Oral TabletPSN4eab4344-d95e-4b19-a21e-9c8ad033863a5
1049160pseudoephedrine HCl 30 MG Oral TabletPSN775f97c0-6f82-49a8-82ac-f1a73920c3ec5
1049160pseudoephedrine hydrochloride 30 MG Oral TabletSCD4eab4344-d95e-4b19-a21e-9c8ad033863a5
1049160pseudoephedrine hydrochloride 30 MG Oral TabletSCD775f97c0-6f82-49a8-82ac-f1a73920c3ec5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0536-3607-35005363607351 BLISTER PACK in 1 CARTON (0536-3607-35) / 24 TABLET in 1 BLISTER PACK1 blister pack2012-10-290000-00-00NoNoCurrent