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 123 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mucinex Childrens Mighty Chews Cold and Flu	ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE	RB Health (US) LLC	2ce20ab5-5f2d-1c97-e063-6394a90ad67b	2025-01-29	Warnings	Exact identifier application number: M012
Guaifenesin and Dextromethorphan	GUAIFENESIN AND DEXTROMETHORPHAN	Major Pharmaceuticals	97b137c9-0bec-409a-91f7-e298c296578b	2025-01-29	Warnings	Exact identifier application number: M012
Childrens Mucus and Cough Relief	DEXTROMETHORPHAN HBR, GUAIFENESIN	CVS	1dc17665-62ce-f7f5-e063-6294a90af851	2025-01-29	Warnings	Exact identifier application number: M012
UP AND UP NO DRIP NASAL	OXYMETAZOLINE HYDROCHLORIDE	Target Corporation	760d6d0f-00fc-40bc-858d-83a0827d139f	2025-01-29	Warnings	Exact identifier application number: M012
Guaifenesin and Dextromethorphan	GUAIFENESIN AND DEXTROMETHORPHAN	Major Pharmaceuticals	51e48201-bb62-4e89-85eb-e4a416f93522	2025-01-29	Warnings	Exact identifier application number: M012
Severe Congestion and Cough Max	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Best Choice	8c878e47-94f4-484f-bdd8-6d87ac2440d8	2025-01-28	Warnings	Exact identifier application number: M012
Cough and Cold Therapy	CAMPHOR, MENTHOL, EUCALYPTUS OIL	Everlaan Organics Inc	088be461-7afc-586a-e063-6294a90a700b	2025-01-27	Warnings	Exact identifier application number: M012
Cough and Cold Therapy For Kids	CAMPHOR, MENTHOL, EUCALYPTUS OIL	Everlaan Organics Inc	088df369-114c-db4f-e063-6394a90acfac	2025-01-27	Warnings	Exact identifier application number: M012
Menthol Cough Drops	MENTHOL	Target Corporation Inc.	eb4c2c3f-91d7-e4c6-e053-2a95a90a4e8a	2025-01-26	Warnings	Exact identifier application number: M012
Walgreens Menthol Cough Drops	MENTHOL	Walgreens	2c62f690-8dfb-d28e-e063-6394a90a45a2	2025-01-23	Warnings	Exact identifier application number: M012
Walgreens Cherry Cough Drops	MENTHOL	Walgreens	2c65d836-e724-50d6-e063-6394a90a0827	2025-01-23	Warnings	Exact identifier application number: M012
Walgreens Honey Lemon Cough Drops	MENTHOL	Walgreens	2c67424c-2fb0-cc15-e063-6394a90a02ca	2025-01-23	Warnings	Exact identifier application number: M012
Pharmacys Prescription Analgesic Gel	MENTHOL	American Consumer Products Corp	6f0725f2-833f-f3a0-e053-2a91aa0a3911	2025-01-23	Warnings	Exact identifier application number: M012
Pharmacys Prescription Vapor Rub	MENTHOL	American Consumer Products Corp	6ef328ff-f5c3-515d-e053-2a91aa0a32d3	2025-01-23	Warnings	Exact identifier application number: M012
Childrens Allergy Relief	DIPHENHYDRAMINE HCL	Best Choice	0035e6a4-b3ef-4e0b-aa7f-7453dd065f4d	2025-01-22	Warnings	Exact identifier application number: M012
GOOD REMEDIES Allergy Relief SOFTGEL	DIPHENHYDRAMINE HYDROCHLORIDE	Strive Pharmaceuticals Inc.	26a02737-2cfd-769f-e063-6394a90af352	2025-01-22	Warnings	Exact identifier application number: M012
Pharbechlor	CHLORPHENIRAMINE MALEATE 4MG	Ulai Health LLC	6a1a5cef-e946-4ba8-9402-557c6adf45f9	2025-01-20	Warnings	Exact identifier application number: M012
Pharbinex	GUAIFENESIN 400MG	Ulai Health LLC	4eafa81a-aeee-4c97-85d6-594902b10919	2025-01-20		Exact identifier application number: M012
Pharbinex-PE	GUAIFENESIN 400MG AND PHENYLEPHRINE HCL 10MG	Ulai Health LLC	e459bb83-b1d6-42fc-aa46-99ad117e6144	2025-01-20		Exact identifier application number: M012
Pharbinex-DM	GUAIFENESIN 400MG AND DEXTROMETHORPHAN HBR 20MG	Ulai Health LLC	af80d10e-3fb2-405a-a803-1f876b8dcd10	2025-01-20		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