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 55 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Relief Extra Strength	DIPHENHYDRAMINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	4f33c1fb-150b-4083-a9a4-c0fbab4b6133	2026-01-27	Warnings	Exact identifier application number: M012
Cold and Flu Daytime Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Meijer Distribution Inc	5ca7dc60-af0c-47c6-b453-8b39c744eb5b	2026-01-27	Warnings	Exact identifier application number: M012
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	HyVee Inc	2ce5f2af-cabc-466f-b0c5-256e6e6d4c88	2026-01-27	Warnings	Exact identifier application number: M012
Sinus Headache and Pain Day, Non-drowsy	ACETAMINOPHEN, PHENYLEPHRINE HCL	ARMY AND AIR FORCE EXCHANGE SERVICE	c33340c0-47d3-45e2-997b-3d9fb148900f	2026-01-27	Warnings	Exact identifier application number: M012
Cold and Flu Daytime Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	L.N.K. International, Inc.	b7501b59-d25a-49ec-9cbf-47018bce8397	2026-01-27	Warnings	Exact identifier application number: M012
good sense nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	L. Perrigo Company	f90bd64a-dd1a-4319-87cd-427d57f677ab	2026-01-26	Warnings	Exact identifier application number: M012
Equate Health Non Drowsy DAY Cold and Flu Plus and NIGHTTIME Cold and Flu Plus	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores Inc	547ff880-3d40-4a4a-84ee-cd0d5290a9b9	2026-01-26	Warnings	Exact identifier application number: M012
Maximum Strength Non Drowsy Day and Night Cold and Flu	MAXIMUM STRENGTH NON DROWSY DAY AND NIGHT COLD AND FLU	WAL-MART STORES INC	d6a35fb8-1899-4da2-ad2b-0423e332845d	2026-01-26	Warnings	Exact identifier application number: M012
MUCUS RELIEF	GUAIFENESIN	Prodose, Inc.	7e5de5b0-18f0-4807-8686-da9821f918ce	2026-01-26	Warnings	Exact identifier application number: M012
ALLERGY RELIEF	DIPHENHYDRAMINE HYDROCHLORIDE	Wal-Mart Stores Inc	b9fbf917-12b7-770f-e053-2995a90afe93	2026-01-26	Warnings	Exact identifier application number: M012
Maximum Strength Non Drowsy Daytime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores Inc	b58b2c36-a403-4dae-b3b2-f0ffd28a963b	2026-01-26	Warnings	Exact identifier application number: M012
Allergy Relief Dye Free	DIPHENHYDRAMINE HCL	Wal-Mart Stores Inc	870e6bcb-84ab-45e0-ae57-08a9a182eb0b	2026-01-26	Warnings	Exact identifier application number: M012
Allergy Relief Dye Free	DIPHENHYDRAMINE HCL	Wal-Mart Stores Inc	eb8e83a4-981b-48a5-88f4-3a0ba358d3bc	2026-01-26	Warnings	Exact identifier application number: M012
NIGHTTIME SEVERE COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores Inc	8d2d765f-a7e3-40e6-b35d-0e8806a7ea59	2026-01-26	Warnings	Exact identifier application number: M012
NIGHTTIME COLD AND FLU CHERRY	PHENYLEPHRINE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, DOXYLAMINE SUCCINATE	Walgreen Company	02a6781c-aa6f-8fb0-e063-6294a90a043d	2026-01-26	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN, DOXYLAMINE SUCCINATE	Walgreen Company	02e5f475-4e9f-2856-e063-6294a90a21fd	2026-01-26	Warnings	Exact identifier application number: M012
GNP Vapor Steam camphor (synthetic)	CAMPHOR (SYNTHETIC)	AmerisourceBergen	0bcc55bf-9654-120b-e063-6394a90a59d1	2026-01-26	Warnings	Exact identifier application number: M012
S2	RACEPINEPHRINE HYDROCHLORIDE	Nephron Pharmaceuticals Corporation	dd1b35c7-b23b-4b95-8162-df3d263fe32e	2026-01-26	Warnings	Exact identifier application number: M012 ndc (product): 0487-5901
SEVERE COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	0d97c634-0975-42d5-8ade-2ed2018cfe9d	2026-01-26	Warnings	Exact identifier application number: M012
GOOD SENSE NIGHT TIME	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	L. Perrigo Company	cd68289b-3850-40c6-9439-aae0e2d7637d	2026-01-26	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