Nasal Decongestant

Product NDC: 21130-112
11-digit product format: 211300112
Labeler code: 21130
Product ID: 21130-112_b6ce85aa-3b57-4635-bc2b-8b9e8b1d6984
Type: HUMAN OTC DRUG
Nonproprietary name: Pseudoephedrine HCl
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Better Living Brands, LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1981-08-25
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

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
Brand name suffix: Maximum Strength
Listing expiration: 2027-12-31

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
9fe63ca6-3863-4175-9aec-ecd6ebbdb249	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
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
b893258d-0942-3d8a-3411-056ea0788ff5	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21130-112-08	Nasal DecongestantMaximum Strength	1 in 1 CARTON	TABLET, FILM COATED	1		15
21130-112-08	Nasal DecongestantMaximum Strength	24 in 1 BLISTER PACK	TABLET, FILM COATED	24		15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIVE INGREDIENT	6V9V2RYJ8N	NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL 30 MG) TABLET, FILM COATED [SAFEWAY]	2
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL 30 MG) TABLET, FILM COATED [SAFEWAY]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL 30 MG) TABLET, FILM COATED [SAFEWAY]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL 30 MG) TABLET, FILM COATED [SAFEWAY]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL 30 MG) TABLET, FILM COATED [SAFEWAY]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL 30 MG) TABLET, FILM COATED [SAFEWAY]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL 30 MG) TABLET, FILM COATED [SAFEWAY]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL 30 MG) TABLET, FILM COATED [SAFEWAY]	2
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL 30 MG) TABLET, FILM COATED [SAFEWAY]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL 30 MG) TABLET, FILM COATED [SAFEWAY]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL 30 MG) TABLET, FILM COATED [SAFEWAY]	2
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL 30 MG) TABLET, FILM COATED [SAFEWAY]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21130-112	NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]	14	Current NDC, Legacy NDC, 2 package rows	20250110_9fe63ca6-3863-4175-9aec-ecd6ebbdb249.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 126 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Tussnex	ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Guardian Drug Company	19e9678d-ac34-4af8-a80f-d08fce0a5f0e	2024-12-19	Warnings	Exact identifier application number: M012
Vaporising Chest Rub	CAMPHOR, MENTHOL, EUCALYPTUS OIL	New Pride Corp	f66476d5-036b-0b1c-e053-2a95a90a0a07	2024-12-19	Warnings	Exact identifier application number: M012
Chest Rub Vaporizing Action	MENTHOL AND CAMPHOR AND EUCALYPTUS OIL	Singhfam Corporation	c6ea663a-9c4f-4d1a-a937-002806a8530a	2024-12-19	Warnings	Exact identifier application number: M012
ELIZABETH HEALTH STYLE CHESTRUB VAPORIZING ACTION	CAMPHOR (SYNTHETIC), LEVOMENTHOL, EUCALYPTUS	Singhfam Corporation	f1e4caee-b50e-a0a6-e053-2a95a90aadce	2024-12-19	Warnings	Exact identifier application number: M012
Leader Vapor Steam camphor (synthetic)	CAMPHOR (SYNTHETIC)	LEADER/Cardinal Health 110, Inc.	ae580e6c-2efd-c788-e053-2995a90a3360	2024-12-19	Warnings	Exact identifier application number: M012
Tussin DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Strategic Sourcing Service, LLC	0b6689db-ea34-9a06-e063-6394a90abaf7	2024-12-19	Warnings	Exact identifier application number: M012
Medicated Chest Rub	CAMPHOR, MENTHOL, EUCALYPTUS OIL	Jell Pharmaceuticals Pvt Ltd.	d80b9cc1-55f5-76d5-e053-2995a90aa967	2024-12-19	Warnings	Exact identifier application number: M012
Health Smart Vaporizing Chest Rub	MENTHOL AND CAMPHOR AND EUCALYPTUS OIL	Home Smart Products	acab200e-48bd-69e1-e053-2995a90afde0	2024-12-19	Warnings	Exact identifier application number: M012
Halls MENTHO-LYPTUS	MENTHOL	Mondelez Global LLC	ff21cf0e-9811-4819-bdfc-17a950e9b114	2024-12-19	Warnings	Exact identifier application number: M012
Tussnex FM Cold, Flu and Sore Throat	ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Guardian Drug Company	7bddce11-c227-4d95-94c1-6f41ecd7285b	2024-12-19	Warnings	Exact identifier application number: M012
Childrens Tussnex Multi-symptom cold	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Guardian Drug Company	9028676e-d725-4afe-aa14-72235825aa17	2024-12-19	Warnings	Exact identifier application number: M012
Tussnex FM Cold and Sinus	ACTEAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Guardian Drug Company	04c6bb6a-d2f8-4322-afba-e240e8090176	2024-12-19	Warnings	Exact identifier application number: M012
Tussnex FM Severe cough and congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Guardian Drug Company	387df403-7803-4031-915e-8de9b103a162	2024-12-19	Warnings	Exact identifier application number: M012
Maximum strength Tussnex FM DM Max	DEXTROMETHORPHAN HBR, GUAIFENESIN	Guardian Drug Company	0bae53e3-9661-4bc6-9fcc-da7fa131b034	2024-12-19	Warnings	Exact identifier application number: M012
Vicks Vaposteam Lavender	CAMPHOR, (-)-	Kaz USA, Inc	03bf6b78-cf8e-44c6-bae0-5bd0a85f8aa9	2024-12-19	Warnings	Exact identifier application number: M012
Refenesen Mucus Relief DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	Reese Pharmaceutical Co	6046dc50-f162-4e2d-aa3c-7d27efad477d	2024-12-18	Warnings	Exact identifier application number: M012
Sunmark Chest Congestion Relief PE PE	GUAIFENESIN/PHENYLEPHRINE	Strategic Sourcing Services LLC	f94ae469-4c79-4ce9-9a3d-3bdc645be6d9	2024-12-18	Warnings	Exact identifier application number: M012
Quality Choice Mucus Relief DM DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	Chain Drug Marketing Association	1c33a01f-1186-4a19-b639-a9cd49245220	2024-12-18	Warnings	Exact identifier application number: M012
HealthMart Chest Congestion Relief	GUAIFENESIN	Strategic Sourcing Services LLC	a5d1a8e8-10ba-4fff-b6f7-18c0fde5155c	2024-12-18	Warnings	Exact identifier application number: M012
DG Health Immediate Release Mucus Relief	GUAIFENESIN	Reese Pharmaceutical Co	f60a9d1b-7a63-43d3-b843-e1f31cf78873	2024-12-18	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	9fe63ca6-3863-4175-9aec-ecd6ebbdb249	15
1049160	pseudoephedrine hydrochloride 30 MG Oral Tablet	SCD	9fe63ca6-3863-4175-9aec-ecd6ebbdb249	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
21130-112-08	21130011208	1 BLISTER PACK in 1 CARTON (21130-112-08) / 24 TABLET, FILM COATED in 1 BLISTER PACK	1 blister pack	1981-08-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Signature Select 44-112	Better Living Brands, LLC \| LNK International, Inc.	2026-01-19	HUMAN OTC DRUG LABEL	15