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 109 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Demoulas Super Markets, Inc	397f5acd-31c0-683e-e063-6394a90a7e54	2025-07-16	Warnings	Exact identifier application number: M012
EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY/NIGHT	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE	Kenvue Brands LLC	19ad2cca-c1cb-019c-e063-6294a90a5644	2025-07-16	Warnings	Exact identifier application number: M012
DG HEALTH COLD FLU RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Dolgencorp Inc	8ea03891-2fbc-4413-8e6d-de903d426f8d	2025-07-16	Warnings	Exact identifier application number: M012
up and up nighttime flu and severe cold and cough	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Target Corporation	df488727-b913-440b-9a0b-cce3ae143bf2	2025-07-15	Warnings	Exact identifier application number: M012
Topcare DayTime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Topco Associates LLC	bb9663e3-fd11-4e72-bf85-fee4841b795f	2025-07-15	Warnings	Exact identifier application number: M012
DG HEALTH COLD FLU RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Dolgencorp Inc	320e4f32-66aa-48be-9afd-fa2b2c217dc1	2025-07-14	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	BETTER LIVING BRANDS LLC.	f29da4ca-443d-7035-e053-2a95a90acab8	2025-07-14	Warnings	Exact identifier application number: M012
CVS PHARMACY MS Adult Severe Multi Symptom Cough Cold Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	CVS PHARMACY	cdc9af7c-3766-4573-9d95-bf217907b932	2025-07-11	Warnings	Exact identifier application number: M012
Health Smart Vaporizing Chest Rub	MENTHOL AND CAMPHOR AND EUCALYPTUS OIL	International Wholesale Inc	398fee3d-7d93-9dbc-e063-6294a90abdcc	2025-07-10	Warnings	Exact identifier application number: M012
HEADACHE RELIEF	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	Kroger Company	bbed29a1-3c52-3531-e053-2995a90a686c	2025-07-10	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	CVS PHARMACY, INC	b765c82e-5021-4772-8647-c5ebc596bc0a	2025-07-10	Warnings	Exact identifier application number: M012
Sinus Pressure and Pain	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	c378acaf-389a-4afb-a4f0-e367a907a468	2025-07-10	Warnings	Exact identifier application number: M012
Nasal Decongestant Non-Drowsy	PSEUDOEPHEDRINE HCL	CVS Pharmacy	3330b077-dab7-45c6-acbb-0f91f2271232	2025-07-09	Warnings	Exact identifier application number: M012
ACTIDOGESIC DF	ACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE	ACTIPHARMA, LLC	ff8e2565-bce3-4c06-a416-6e8f369f057f	2025-07-09	Warnings	Exact identifier application number: M012
ACTINEL	DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL	ACTIPHARMA, LLC	db0cb6ae-0a4d-4232-805a-f3f3a058261f	2025-07-08	Warnings	Exact identifier application number: M012
HALLS Extra Strong	MENTHOL	Mondelez Global LLC	396f93a9-8d2c-2f27-e063-6294a90ab344	2025-07-08	Warnings	Exact identifier application number: M012
ACTICON	DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIPHARMA, LLC	aea0335d-75e6-4a90-86a5-f197cf024a11	2025-07-08	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	P & L Development, LLC	0bb006f6-c360-4cd5-81e9-0776d99d79e8	2025-07-08	Warnings	Exact identifier application number: M012
childrens cold cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Meijer, Inc.	026e530f-e133-4f20-bac5-354fbb647c9e	2025-07-08	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	CVS PHARMACY, INC	f59016f3-a8f8-4c95-9414-01440f0574d9	2025-07-08	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