S2

Product NDC: 0487-5901
11-digit product format: 004875901
Labeler code: 0487
Product ID: 0487-5901_495453e6-2060-edaa-e063-6394a90a8a5d
Type: HUMAN OTC DRUG
Nonproprietary name: racepinephrine hydrochloride
Dosage form: SOLUTION
Route: RESPIRATORY (INHALATION)
Labeler: Nephron Pharmaceuticals Corporation
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2000-01-01
Substance: RACEPINEPHRINE HYDROCHLORIDE
Active strength: 11.25 mg/.5mL
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: S2
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RACEPINEPHRINE HYDROCHLORIDE	11.25 mg/.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
336096P2WE	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310133	Internal RxNorm lookup
863968	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
dd1b35c7-b23b-4b95-8162-df3d263fe32e	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0487-5901-99	S2	30 in 1 CARTON	SOLUTION	30		12
0487-5901-99	S2	1 in 1 POUCH	SOLUTION	1		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0487-5901-02	EA - Each	0487-5901	e4fa89c2-def9-4c41-9c97-ccaf02f5b5cf	1	2012-07-24
0487-5901-10	EA - Each	0487-5901	4e462d6e-f2d0-4ea7-bcfa-2073e6f5109f	1	2013-02-13
0487-5901-99	EA - Each	0487-5901	530e7c42-5bd7-483e-96d6-682b76349b33	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
RACEPINEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	336096P2WE	S2 (RACEPINEPHRINE HYDROCHLORIDE) SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION]	7
RACEPINEPHRINE	ACTIVE MOIETY	GR0L9S3J0F	S2 (RACEPINEPHRINE HYDROCHLORIDE) SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION]	7
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	S2 (RACEPINEPHRINE HYDROCHLORIDE) SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION]	7
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	S2 (RACEPINEPHRINE HYDROCHLORIDE) SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION]	7
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	S2 (RACEPINEPHRINE HYDROCHLORIDE) SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION]	7
WATER	INACTIVE INGREDIENT	059QF0KO0R	S2 (RACEPINEPHRINE HYDROCHLORIDE) SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0487-5901	S2 (RACEPINEPHRINE HYDROCHLORIDE) SOLUTION [NEPHRON SC, INC.]	11	Current NDC, Legacy NDC, 2 package rows	20241222_dd1b35c7-b23b-4b95-8162-df3d263fe32e.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 91 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TARGET Childrens Cold and Cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	TARGET CORPORATION	bfc91c71-0506-4e94-8bfe-dc9e4bf959da	2025-11-07	Warnings	Exact identifier application number: M012
CHILDRENS COLD AND COUGH	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	H E B	08f4785a-c628-4e9b-9412-b2a817f9be60	2025-11-07	Warnings	Exact identifier application number: M012
G-TUSICOF	DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE	Kramer Novis	d169585f-b4f4-4831-8c71-e1533ae7e7c4	2025-11-07	Warnings	Exact identifier application number: M012
Cold and Flu Relief	ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL	QUALITY CHOICE (Chain Drug Marketing Association)	1d512053-7a54-4691-a657-77da4c627cb8	2025-11-07	Warnings	Exact identifier application number: M012
Allergy and Headache	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	dc249163-26dd-42ca-b423-2f16299f2d65	2025-11-07	Warnings	Exact identifier application number: M012
Sinus Congestion	PSEUDOEPHEDRINE HCL	Chain Drug Marketing Association, Inc.	9744d04d-298d-4acd-9470-db9e7f2901e7	2025-11-07	Warnings	Exact identifier application number: M012
Daytime, Nighttime Severe Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	c3b7fab1-f7fe-41be-a1c4-7ba4ba23c159	2025-11-07	Warnings	Exact identifier application number: M012
Severe Cold and Flu Relief Daytime/Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL	ARMY AND AIR FORCE EXCHANGE SERVICE	1c0c562a-68dc-4e9a-b8f3-ae70b9a4948e	2025-11-07	Warnings	Exact identifier application number: M012
Vicks DayQuil HIGH BLOOD PRESSURE COLD and FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	The Procter & Gamble Manufacturing Company	ff0bffee-9a36-8246-e053-6294a90a86c7	2025-11-06	Warnings	Exact identifier application number: M012
Xlear Nasal Decongestant	NASAL SPRAY	Xlear Inc.	1c1db71a-47d0-42ac-8cbe-95e76dca185f	2025-11-06	Warnings	Exact identifier application number: M012
Robitussin Honey Cough DM Day Night Value Pack	DEXTROMETHORPHAN HBR, GUAIFENESIN, DOXYLAMINE SUCCINATE	Haleon US Holdings LLC	1bbd0157-06e6-4a3b-bac9-91ac879ba089	2025-11-06	Warnings	Exact identifier application number: M012
ValuMeds Nasal Decongestant Phenylephrine HCl	PHENYLEPHRINE HYDROCHLORIDE	Cabinet Health P.B.C.	21676b0c-6be2-464c-ae91-92e5f0d0087d	2025-11-06	Warnings	Exact identifier application number: M012
COLD AND FLU SEVERE Daytime, Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Meijer Distribution, Inc.	04715af5-e861-496c-834a-233eb7312556	2025-11-06	Warnings	Exact identifier application number: M012
Severe Allergy Plus Sinus Headache	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Wal-Mart Stores Inc	1a1f41c4-5430-4cff-873e-6547dadc8779	2025-11-06	Warnings	Exact identifier application number: M012
Target Overnight Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL	TARGET CORPORATION	05e944d5-3473-4d8c-8df4-2ffc7474e9fa	2025-11-05	Warnings	Exact identifier application number: M012
Target Cough plus Chest Congestion DM Max with Honey	DEXTROMETHORPHAN HBR, GUAIFENESIN	TARGET CORPORATION	e36f179e-5aed-4fee-8b0a-767bf3590752	2025-11-05	Warnings	Exact identifier application number: M012
Target Maximum Strength Cold Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	TARGET CORPORATION	1d3ad31f-ef4d-45ba-a6e3-13d66b51d1d2	2025-11-05	Warnings	Exact identifier application number: M012
Up and Up maximum Strength fast mucus relief Severe Congestion and Cough	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Target Corporation	f007beaa-b108-46d5-8a98-853f011a8e2e	2025-11-05	Warnings	Exact identifier application number: M012
Target Childrens Cough Relief	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	TARGET CORPORATION	975e157a-8f8d-41ad-b55b-9f9100188ccd	2025-11-05	Warnings	Exact identifier application number: M012
Target Maximum Strength Cold Flu and Sore Throat Overnight Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL AND TRIPROLIDINE HCL	TARGET CORPORATION	6e94fdab-27ea-4c0f-a91c-735ce697304b	2025-11-05	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
336096P2WE	RACEPINEPHRINE HYDROCHLORIDE	329-63-5	RACEPINEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310133	racepinephrine 2.25 % Inhalation Solution	PSN	dd1b35c7-b23b-4b95-8162-df3d263fe32e	12
863968	S-2, 2.25 % Inhalation Solution	PSN	dd1b35c7-b23b-4b95-8162-df3d263fe32e	12
863968	racepinephrine 22.5 MG/ML Inhalation Solution [S-2]	SBD	dd1b35c7-b23b-4b95-8162-df3d263fe32e	12
310133	racepinephrine 22.5 MG/ML Inhalation Solution	SCD	dd1b35c7-b23b-4b95-8162-df3d263fe32e	12
310133	racepinephrine 11.25 MG per 0.5 ML Inhalation Solution	SY	dd1b35c7-b23b-4b95-8162-df3d263fe32e	12
310133	racepinephrine 2.25 % Inhalation Solution	SY	dd1b35c7-b23b-4b95-8162-df3d263fe32e	12
863968	S-2 11.25 MG (racepinephrine hydrochloride 13.5 MG) per 0.5 ML Inhalation Solution	SY	dd1b35c7-b23b-4b95-8162-df3d263fe32e	12
863968	S-2 2.25 % Inhalation Solution	SY	dd1b35c7-b23b-4b95-8162-df3d263fe32e	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0487-5901-99	00487590199	30 POUCH in 1 CARTON (0487-5901-99) / 1 VIAL, SINGLE-USE in 1 POUCH / .5 mL in 1 VIAL, SINGLE-USE	30 pouch	2000-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Racepinephrine Inhalation Solution, USP 2.25%	Nephron Pharmaceuticals Corporation \| Nephron SC, LLC	2026-01-26	HUMAN OTC DRUG LABEL	12
Racepinephrine Inhalation Solution, USP 2.25%	NuCare Pharmaceuticals,Inc.	2021-02-22	HUMAN OTC DRUG LABEL	2

S2