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 124 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Right Remedies Adult Long Lasting Cough Relief Softgel	DEXTROMETHORPHAN HYDROBROMIDE	Strive Pharmaceuticals Inc.	e3ea468e-4e12-4dae-b222-8e32456b77b8	2025-01-02	Warnings	Exact identifier application number: M012
AVON HeXashield Congestion Relief Original	OXYMETAZOLINE HYDROCHLORIDE	Tai Guk Pharm. Co., Ltd.	8f2c152c-c564-0cba-e053-2a95a90ab3c7	2025-01-01	Warnings	Exact identifier application number: M012
Multi-Symptom Nighttime Cold and Flu Relief	ACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HBR	Advanced Rx LLC	a75553bd-f3f0-47bd-b3c3-aeeb0d1a81b4	2025-01-01	Warnings	Exact identifier application number: M012
Cough Relief	DEXTROMETHORPHAN HYDROBROMIDE	Advanced Rx LLC	297e10e3-e740-4434-91a2-2e5c54985d33	2025-01-01	Warnings	Exact identifier application number: M012
MUCUS RELIEF DM	GUAIFENESIN, DEXTROMETHORPHAN HBR	Advanced Rx LLC	64620186-a45b-4c35-a3b9-a347348f93f7	2025-01-01	Warnings	Exact identifier application number: M012
DM Max	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Best Choice	57a44bbf-a304-47b9-8adc-4442c7787853	2025-01-01	Warnings	Exact identifier application number: M012
Long Acting Cough Softgels	DEXTROMETHORPHAN HYDROBROMIDE	CVS PHARMACY, INC	322daee6-c61d-43d3-a54d-a354fd3df242	2025-01-01	Warnings	Exact identifier application number: M012
Adult Tussin DM Lil Drug Store Products	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	Lil' Drug Store Products, Inc	1915cf2a-ebaa-4c47-8991-5b741fa01be2	2024-12-31	Warnings	Exact identifier application number: M012
Congestion Relief Lil Drug Store Products	OXYMETAZOLINE HYDROCHLORIDE	Lil' Drug Store Products, Inc	8fca348c-ecb6-4a91-89dd-8bd4c05ac745	2024-12-31	Warnings	Exact identifier application number: M012
DAYTIME COLD AND FLU MULTI SYMPTOM	DAYTIME COLD AND FLU MULTI SYMPTOM	TARGET CORP	9dea350d-2f09-b944-e053-2995a90a2b63	2024-12-30	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Walgreens	2b7aa3f5-3bc9-471f-8ff7-3c52719f0acb	2024-12-30	Warnings	Exact identifier application number: M012
Pediacare Childrens Cough and Cold Grape	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH	fabafdc1-9dd8-4258-af49-bab1e29ad109	2024-12-30	Warnings	Exact identifier application number: M012
Pediacare Childrens Cough and Congestion Grape	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH	9576723b-748c-45e7-bc0d-cc109b9f6735	2024-12-30	Warnings	Exact identifier application number: M012
Cold and Flu Nighttime Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Lil' Drug Store Products, Inc.	ef6836fa-d104-d7b3-e053-2a95a90af2b8	2024-12-30	Warnings	Exact identifier application number: M012
Circle K Congestion Relief	OXYMETAZOLINE HYDROCHLORIDE	Lil' Drug Store Products, Inc	7e02fe57-f42f-4d3c-9002-4c4c0b1fafd6	2024-12-30	Warnings	Exact identifier application number: M012
SDA Laboratories Tussin	GUAIFENESIN	SDA Laboratories, Inc.	2a444cc8-96be-9432-e063-6394a90a1b63	2024-12-27	Warnings	Exact identifier application number: M012
SDA Laboratories Tussin DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	SDA Laboratories, Inc.	2a445f31-818d-11b1-e063-6294a90a8cb1	2024-12-27	Warnings	Exact identifier application number: M012
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Richmond Pharmaceuticals Inc.	f184b2aa-91a4-44f9-b688-d4e318181984	2024-12-26	Warnings	Exact identifier application number: M012
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Richmond Pharmaceuticals, Inc.	2792032a-ff0f-4d5f-a8e3-b8b8c54f4e99	2024-12-26	Warnings	Exact identifier application number: M012
OXYMETAZOLINE HYDROCHLORIDE	OXYMETAZOLINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC.	c7b1f980-9b0d-4f63-a70d-fd366658f863	2024-12-26	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