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 107 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DISCOUNT DRUG MART	COUGH DROPS VITAMIN C SUGAR-FREE	DISCOUNT DRUG MART	06673358-1afc-4d75-e063-6394a90a6ab1	2025-09-03	Warnings	Exact identifier application number: M012
ValuMeds Cough Relief, Dextromethorphan Hbr	DEXTROMETHORPHAN HYDROBROMIDE	Cabinet Health P.B.C.	b16a81db-d9bc-4cce-8ec2-dc189184931e	2025-09-03	Warnings	Exact identifier application number: M012
topcare day time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	256d96f0-67bf-42d2-85ef-f49625c5910f	2025-09-02	Warnings	Exact identifier application number: M012
TOPCARE HONEY FLAVOR COLD AND FLU RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	2256623c-7642-4c39-b022-bfaecc861f1c	2025-09-02	Warnings	Exact identifier application number: M012
topcare nite time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	ef574f18-e28d-46bb-87fd-2f3b4df6dc68	2025-09-02	Warnings	Exact identifier application number: M012
Cold Multi-Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Kroger Company	f4429475-47f9-451a-bfcc-24b5ef333923	2025-09-02	Warnings	Exact identifier application number: M012
dg health night time cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Dolgencorp Inc	dc8cc7a3-60a9-42f0-babd-d3c7d0276dd1	2025-08-29	Warnings	Exact identifier application number: M012
MGC Health Cough Drops Original Herb	MENTHOL	Medical Group Care LLC	3d70ba70-eb11-f148-e063-6294a90a4c7c	2025-08-28	Warnings	Exact identifier application number: M012
Exchange Select Cough Drops Original Herb	MENTHOL	Army & Air Force Exchange Service	3d7109a5-4fe1-039b-e063-6394a90a1392	2025-08-28	Warnings	Exact identifier application number: M012
MGC Health Cough Drops Honey Herb	MENTHOL	Medical Group Care LLC	3d710deb-e42d-13eb-e063-6394a90a56e1	2025-08-28	Warnings	Exact identifier application number: M012
Sinus Relief Pressure and Pain	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Kroger Company	98de5cff-3ff5-49b0-bef9-5b9ebb86491e	2025-08-27	Warnings	Exact identifier application number: M012
Nighttime SEVERE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	H E B	0a178114-0748-4a92-9b60-a7a0a8b72287	2025-08-26	Warnings	Exact identifier application number: M012
Adult Bisolvine Adult	GUAIFENESIN, DEXTROMETHORPHAN	MENPER DISTRIBUTORS INC.	8cde5e39-a338-45af-b847-3823627f29c5	2025-08-25	Warnings	Exact identifier application number: M012
Pain Reliever PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Strategic Sourcing Services LLC	997eb228-09cb-47ad-acbb-363b05c67635	2025-08-25	Warnings	Exact identifier application number: M012
QUALITY CHOICE Childrens Allergy Relief DYE FREE	DIPHENHYDRAMINE HYDROCHLORIDE	QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)	644f39d8-7cd6-43dd-9265-546d01d32e8c	2025-08-22	Warnings	Exact identifier application number: M012
SanaTos Multi Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI	Pharmadel LLC	df260190-89e7-b338-e053-2995a90a32cb	2025-08-22	Warnings	Exact identifier application number: M012
Geri-Dryl allergy relief	DIPHENHYDRAMINE HCL	VerityRx	9ca6c0f8-71d1-4953-8e98-3311c4664011	2025-08-22	Warnings	Exact identifier application number: M012
SU PHEDRINE PE Non-Drowsy, Maximum Strength	PHENYLEPHRINE HCL	Salado Sales, Inc.	9056fa58-d6aa-4df5-97e0-9be3f2332f86	2025-08-22	Warnings	Exact identifier application number: M012
Chest Rub	CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL	MY IMPORTS USA LLC	3cde0c23-5c5c-9715-e063-6294a90a9462	2025-08-21	Warnings	Exact identifier application number: M012
Severe Cold Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	CVS Pharmacy	258d27a9-fea6-4076-8dfa-77c7e982d250	2025-08-20	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