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

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
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PSEUDOEPHEDRINE HYDROCHLORIDE	30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6V9V2RYJ8N	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
775f97c0-6f82-49a8-82ac-f1a73920c3ec	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99	Product name	1	20250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767	Product name	4	20250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2	Product name	5	20250304
334fe8d2-68fb-4331-a576-420e302ec069	Product name	7	20240320
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
e92765c1-be81-432a-b909-1b10777ec378	Product name	1	20190208
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
0441a8f5-3835-497c-aedd-bc78cba56b2a	Product name	1	20150317
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66	Product name	1	20140508
70a83adc-6047-bbea-5a08-dfd304aa47d2	Product name	1	20140508
858ce051-9941-aafc-8c7c-44a8e0227463	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
b893258d-0942-3d8a-3411-056ea0788ff5	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0536-3607-35	Nasal Decongestant	24 in 1 BLISTER PACK	TABLET	24		5
0536-3607-35	Nasal Decongestant	1 in 1 CARTON	TABLET	1		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0536-3607-35	EA - Each	0536-3607	42467ecb-1fff-4285-879d-82d9e9b9aa0e	1	2013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIVE INGREDIENT	6V9V2RYJ8N	NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [RUGBY LABORATORIES]	1
PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIVE INGREDIENT	6V9V2RYJ8N	NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [PROFICIENT RX LP]	1
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [PROFICIENT RX LP]	1
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [RUGBY LABORATORIES]	1
12-HYDROXYSTEARIC ACID	INACTIVE INGREDIENT	933ANU3H2S	NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [PROFICIENT RX LP]	1
12-HYDROXYSTEARIC ACID	INACTIVE INGREDIENT	933ANU3H2S	NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [RUGBY LABORATORIES]	1
ACER SACCHARUM POLLEN	INACTIVE INGREDIENT	V38QUQ7861	NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [RUGBY LABORATORIES]	1
ACER SACCHARUM POLLEN	INACTIVE INGREDIENT	V38QUQ7861	NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [PROFICIENT RX LP]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [RUGBY LABORATORIES]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [PROFICIENT RX LP]	1
CALCIUM SULFATE	INACTIVE INGREDIENT	WAT0DDB505	NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [RUGBY LABORATORIES]	1
CALCIUM SULFATE	INACTIVE INGREDIENT	WAT0DDB505	NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [PROFICIENT RX LP]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [RUGBY LABORATORIES]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [PROFICIENT RX LP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [RUGBY LABORATORIES]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [PROFICIENT RX LP]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [PROFICIENT RX LP]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [RUGBY LABORATORIES]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [RUGBY LABORATORIES]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [PROFICIENT RX LP]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [PROFICIENT RX LP]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [RUGBY LABORATORIES]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [PROFICIENT RX LP]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [RUGBY LABORATORIES]	1
KAOLIN	INACTIVE INGREDIENT	24H4NWX5CO	NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [PROFICIENT RX LP]	1
KAOLIN	INACTIVE INGREDIENT	24H4NWX5CO	NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [RUGBY LABORATORIES]	1
MAGNESIUM SILICATE	INACTIVE INGREDIENT	9B9691B2N9	NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [PROFICIENT RX LP]	1
MAGNESIUM SILICATE	INACTIVE INGREDIENT	9B9691B2N9	NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [RUGBY LABORATORIES]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [RUGBY LABORATORIES]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [PROFICIENT RX LP]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [PROFICIENT RX LP]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [RUGBY LABORATORIES]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [PROFICIENT RX LP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [RUGBY LABORATORIES]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [RUGBY LABORATORIES]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [PROFICIENT RX LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0536-3607	NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [RUGBY LABORATORIES]	5	Current NDC, Legacy NDC, 2 package rows	20240112_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 76 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Good Sense Cherry Cough Drops	MENTHOL	Geiss, Destin, Dunn	c72db7f0-9324-8ed2-e053-2995a90a9868	2025-12-12	Warnings	Exact identifier application number: M012
Good Sense Honey Lemon Cough Drops	MENTHOL	Geiss, Destin, Dunn	c72e557f-0211-81b9-e053-2995a90a1437	2025-12-12	Warnings	Exact identifier application number: M012
Good Sense Cherry Benzocaine Lozenges	BENZOCAINE	Geiss, Destin, Dunn	c7404c94-09eb-5cc5-e053-2995a90af021	2025-12-12	Warnings	Exact identifier application number: M012
Good Sense SF Honey Lemon Cough Drops	MENTHOL	Geiss, Destin, Dunn	e11ed21f-6ceb-5908-e053-2995a90aea46	2025-12-12	Warnings	Exact identifier application number: M012
Severe Congestion Relief Maximum Strength Sinus	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Wal-Mart Stores Inc	59918b8b-5c91-468f-834e-66020dc1ae12	2025-12-12	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	SALADO SALES INC.	8f66f5bc-7c77-420b-9feb-911c980fbfdc	2025-12-12	Warnings	Exact identifier application number: M012
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	WALMART INC.	de55a9fd-53a2-4f3e-82b7-cabcbe287d46	2025-12-12	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE	SALADO SALES INC.	cc73b668-cc6a-41d6-800a-4988c59c0449	2025-12-12	Warnings	Exact identifier application number: M012
Allergy Relief	CHLORPHENIRAMINE MALEATE	CHAIN DRUG MARKETING ASSOCIATION INC	75269bcc-3bb2-49a0-8788-6b7da18796d3	2025-12-12	Warnings	Exact identifier application number: M012
Suphedrine PE Sinus plus Allergy	CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	ARMY AND AIR FORCE EXCHANGE SERVICE	affac07f-d645-4999-98ee-7467902f5adc	2025-12-12	Warnings	Exact identifier application number: M012
Sinus Congestion and Pain Relief Non-Drowsy	ACETAMINOPHEN, PHENYLEPHRINE HCL	WinCo Foods, LLC	f7e925f4-7da6-4157-a97f-e6a3e399911f	2025-12-11	Warnings	Exact identifier application number: M012
Sinus Relief Severe Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CARDINAL HEALTH	645f8075-e33f-4e1a-9249-7368261cdcb9	2025-12-11	Warnings	Exact identifier application number: M012
Geri-Tussin	GUAIFENESIN	Geri-Care Pharmaceuticals, Corp	8fd0071b-c6ca-49e6-b159-45dead71b664	2025-12-11	Warnings	Exact identifier application number: M012
Geri-Tussin DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Geri-Care Pharmaceuticals, Corp	098582dc-3e12-782f-e063-6394a90aa1a1	2025-12-11	Warnings	Exact identifier application number: M012
GUAIASORB DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Geri-Care Pharmaceuticals, Corp	09866b9c-aa32-45eb-e063-6394a90a4903	2025-12-11	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	VALU MERCHANDISERS COMPANY	d6947661-a6dd-4bc4-a0ca-932db1840f58	2025-12-11	Warnings	Exact identifier application number: M012
Mucus Relief Sinus Severe Congestion Relief	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	VALU MERCHANDISERS COMPANY	2e751d67-51b4-4b74-a9e8-7f3bc5636984	2025-12-11	Warnings	Exact identifier application number: M012
Pressure and Pain Plus Mucus PE	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	VALU MERCHANDISERS COMPANY	232acb86-7383-4992-b333-1e47bf7c06ad	2025-12-11	Warnings	Exact identifier application number: M012
Sinus Pressure plus Pain PE	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	VALU MERCHANDISERS COMPANY	72847721-9f59-4af1-8f20-dc8449742918	2025-12-11	Warnings	Exact identifier application number: M012
Cold plus Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	VALU MERCHANDISERS COMPANY	f6401317-0295-14b3-e053-2a95a90acbb4	2025-12-11	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6V9V2RYJ8N	PSEUDOEPHEDRINE HYDROCHLORIDE	345-78-8	PSEUDOEPHEDRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1049160	pseudoephedrine HCl 30 MG Oral Tablet	PSN	4eab4344-d95e-4b19-a21e-9c8ad033863a	5
1049160	pseudoephedrine HCl 30 MG Oral Tablet	PSN	775f97c0-6f82-49a8-82ac-f1a73920c3ec	5
1049160	pseudoephedrine hydrochloride 30 MG Oral Tablet	SCD	4eab4344-d95e-4b19-a21e-9c8ad033863a	5
1049160	pseudoephedrine hydrochloride 30 MG Oral Tablet	SCD	775f97c0-6f82-49a8-82ac-f1a73920c3ec	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0536-3607-35	00536360735	1 BLISTER PACK in 1 CARTON (0536-3607-35) / 24 TABLET in 1 BLISTER PACK	1 blister pack	2012-10-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Equaline 44-112	Proficient Rx LP	2024-10-01	HUMAN OTC DRUG LABEL	5
1004 - Rugby	Rugby Laboratories	2024-01-11	HUMAN OTC DRUG LABEL	5