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 52 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sinus and Headache Daytime	ACETAMINOPHEN, PHENYLEPHRINE HCL	DOLGENCORP, LLC	869e950c-5861-4840-aaad-b0342790d62b	2026-02-10	Warnings	Exact identifier application number: M012
CareOne Night TIme Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	American Sales Company	d6b9fb27-3ef7-47ee-81f2-b9a3ccd6de25	2026-02-10	Warnings	Exact identifier application number: M012
Medique Cold Cough Product	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL ,	Sportpharm LLC	d61df3a4-8ae2-46b1-b322-7f4e04cc1bf9	2026-02-09	Warnings	Exact identifier application number: M012
Sinus Congestion and Pain Daytime	ACETAMINOPHEN AND PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	f3fc270a-92fc-46d5-b187-44e875c3abb9	2026-02-09	Warnings	Exact identifier application number: M012
Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	L.N.K. International, Inc.	d5c8b248-6d82-4eac-881c-0b9d0a0de8f1	2026-02-09	Warnings	Exact identifier application number: M012
DayTime/NiteTime Severe Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Meijer Distribution Inc	d07112dd-27df-46cc-b7c3-af8ba7601d06	2026-02-09	Warnings	Exact identifier application number: M012
TYLENOL Cold Plus Flu Multi-Symptom Liquid Gels Day Plus Night	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE	Kenvue Brands LLC	48f7933e-6582-638c-e063-6394a90abfe5	2026-02-06	Warnings	Exact identifier application number: M012
Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Retail Business Services, LLC	4fb46860-2bf9-41a7-89eb-31c259c61107	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M012
pseudoephedrine hydrochloride	PSEUDOEPHEDRINE HCL	Sportpharm LLC	909dacfa-50d3-4bcf-b2df-5405427cfaad	2026-02-06	Warnings	Exact identifier application number: M012
Good Sense Nasal	OXYMETAZOLINE HYDROCHLORIDE	Sportpharm LLC	f91b7c1f-e074-4767-b9c8-dbf1937a6a0f	2026-02-06	Warnings	Exact identifier application number: M012
Severe Allergy And Sinus Headache Maximum Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	CVS Pharmacy	b3c744b8-aa93-505d-f8cf-07995da4283d	2026-02-06	Warnings	Exact identifier application number: M012
NightTime Cold and Flu Multi Symptom	ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DOXYLAMINE SUCCINATE	WinCo Foods, LLC	911e6a51-c0f0-491a-b70c-00011ed5e35b	2026-02-06	Warnings	Exact identifier application number: M012
Severe Sinus Daytime, Non-Drowsy	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	cc0dc951-5024-4517-9d38-a01699407e7e	2026-02-06	Warnings	Exact identifier application number: M012
Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Pharmacy Value Alliance, LLC	d836c3e2-3b69-41f3-b166-21270550e8ab	2026-02-05	Warnings, Adverse reactions	Exact identifier application number: M012
Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Publix Super Markets, Inc.	81b1d5bb-f813-4f79-9559-2494db33ad3c	2026-02-05	Warnings, Adverse reactions	Exact identifier application number: M012
Nasal	OXYMETAZOLINE HYDROCHLORIDE	Kroger Company	6499f854-2995-48cb-9c80-be6524b3db43	2026-02-05	Warnings	Exact identifier application number: M012
Cold and Flu plus Congestion Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	WALMART INC.	52a398eb-e593-458b-9c42-6f653ca391be	2026-02-04	Warnings	Exact identifier application number: M012
Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Hy-Vee, Inc.	446de381-6685-748d-e063-6394a90a1b73	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M012
Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	85aadc86-d979-41a1-849a-e2ccc9014429	2026-02-04	Warnings	Exact identifier application number: M012
severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	HyVee Inc	fa8c154c-56c6-47de-8e43-9e012b4be95f	2026-02-04	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