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 58 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mixed Berry Throat and Cough Lozenges	BENZOCAINE	CVS Pharmacy	737b1c88-1a44-68cf-e053-2991aa0a35b6	2026-01-16	Warnings	Exact identifier application number: M012
Walgreens Wild Cherry Throat Drops	PECTIN	Walgreens	4885eca3-c1e9-8350-e063-6394a90ac290	2026-01-16	Warnings	Exact identifier application number: M012
HBP Chest Congestion and Cough Relief	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	Walgreens	ff7a1462-9994-4421-85aa-c03488bb04cf	2026-01-16	Warnings	Exact identifier application number: M012
Cough Relief	DEXTROMETHORPHAN HBR	WALGREEN COMPANY	a793acbc-107c-4638-a2d7-65f4e96cafda	2026-01-16	Warnings	Exact identifier application number: M012
MUCUS RELIEF DM	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	Walgreens	ca53ec26-d167-1780-e053-2a95a90a5b88	2026-01-16	Warnings	Exact identifier application number: M012
Maximum Strength Congestion and Headache	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Walgreens	88da92d2-92c2-445a-9b70-58996e086014	2026-01-16	Warnings	Exact identifier application number: M012
Maximum Strength Cold and Flu	ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Walgreens	5f638bca-55c2-4ead-8c47-3f15713495da	2026-01-16	Warnings	Exact identifier application number: M012
COLD, Flu and Sore Throat	ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Walgreens	190175bb-c08a-4050-aacf-29a130cbe05c	2026-01-16	Warnings	Exact identifier application number: M012
Night Time Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	FSA Store Inc. (Caring Mills)	a9bd1efc-51c7-40d0-a4f8-f130ce5b45ff	2026-01-16	Warnings	Exact identifier application number: M012
Allergy Multi-Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	L.N.K. International, Inc.	99147338-f459-4423-ae54-f96fffc1728d	2026-01-15	Warnings	Exact identifier application number: M012
SanaTos Severe Cold Relief Nighttime	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Pharmadel LLC	144aafcc-6ec2-a322-e063-6294a90afc27	2026-01-15	Warnings	Exact identifier application number: M012
SanaTos Severe Cold and Cough Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Pharmadel LLC	14484bf5-ff45-b859-e063-6394a90a9a0f	2026-01-15	Warnings	Exact identifier application number: M012
Foster and Thrive Chest Congestion Relief PE PE	GUAIFENESIN/PHENYLEPHRINE	Strategic Sourcing Services LLC	3429aedc-e83d-498a-bfca-03aaf5847b3b	2026-01-15	Warnings	Exact identifier application number: M012
Quality Choice Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Chain Drug Marketing Association	4b86101c-00f8-4ede-807f-db4273b37b8d	2026-01-15	Warnings	Exact identifier application number: M012
Quality Choice Mucus Relief DM DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	Chain Drug Marketing Association	d1ba7267-6844-4a14-b518-65277a32e855	2026-01-15	Warnings	Exact identifier application number: M012
ACTINEL DM Pediatric	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	ACTIPHARMA, LLC	f85d8586-423f-48a3-9bb2-bbc5984c7cd3	2026-01-15	Warnings	Exact identifier application number: M012
ACTINEL Diabetic	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	ACTIPHARMA, LLC	35c21623-84dd-4151-b35b-e7d30b69c9c0	2026-01-15	Warnings	Exact identifier application number: M012
Pocket Farmacy	MENTHOL	Saje Natural Business Inc.	bdc15c6f-73b4-488e-9134-e70565df71bb	2026-01-14	Warnings	Exact identifier application number: M012
Allergy Relief Diphenhydramine HCL 50 MG	DIPHENHYDRAMINE HCL	YYBA Corporation	4b012549-3958-43c1-9de7-897c5d8b20d3	2026-01-14	Warnings	Exact identifier application number: M012
Rite Aid Pharmacy congestion relief vaporizing steam	VAPORIZING STEAM	Rite Aid Pharmacy	0fb86b23-0313-8fd8-e063-6394a90a0f5f	2026-01-14	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