Soothe Night Time

Product NDC: 24208-313
11-digit product format: 242080313
Labeler code: 24208
Product ID: 24208-313_22e15dc4-1977-7228-e063-6394a90a679a
Type: HUMAN OTC DRUG
Nonproprietary name: white petrolatum mineral oil
Dosage form: OINTMENT
Route: OPHTHALMIC
Labeler: Bausch & Lomb Incorporated
Application: M018
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2011-11-15
Substance: MINERAL OIL; PETROLATUM
Active strength: 200; 800 mg/g; mg/g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product	24208-313		E	Excluded after deficient or non-compliant submission was not corrected		excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	24208-313	24208-313-34	E	Excluded after deficient or non-compliant submission was not corrected		excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`

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: Soothe Night Time
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MINERAL OIL	200 mg/g
PETROLATUM	800 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
T5L8T28FGP	Internal UNII lookup
4T6H12BN9U	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
259196	Internal RxNorm lookup
1235262	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
638d3c3f-9960-43da-956e-0e28c77f533e	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
24208-313-34	Soothe Night Time	3.5 g in 1 TUBE	OINTMENT	3.5		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
24208-313-34	GM - Gram	24208-313	8ba2d21d-2b7d-4273-912c-20b17dfde805	1	2025-08-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MINERAL OIL	ACTIVE INGREDIENT	T5L8T28FGP	SOOTHE NIGHT TIME (WHITE PETROLATUM MINERAL OIL) OINTMENT [BAUSCH & LOMB INCORPORATED]	1
PETROLATUM	ACTIVE INGREDIENT	4T6H12BN9U	SOOTHE NIGHT TIME (WHITE PETROLATUM MINERAL OIL) OINTMENT [BAUSCH & LOMB INCORPORATED]	1
MINERAL OIL	ACTIVE MOIETY	T5L8T28FGP	SOOTHE NIGHT TIME (WHITE PETROLATUM MINERAL OIL) OINTMENT [BAUSCH & LOMB INCORPORATED]	1
PETROLATUM	ACTIVE MOIETY	4T6H12BN9U	SOOTHE NIGHT TIME (WHITE PETROLATUM MINERAL OIL) OINTMENT [BAUSCH & LOMB INCORPORATED]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
24208-313	SOOTHE NIGHT TIME (WHITE PETROLATUM MINERAL OIL) OINTMENT [BAUSCH & LOMB INCORPORATED]	8	Current NDC, Legacy NDC, 1 package rows	20240927_638d3c3f-9960-43da-956e-0e28c77f533e.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 19 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eye Wash	WATER	Hubei Changjian Medical Products Co., Ltd.	d57e1c5b-1edc-4a94-88bc-f9ecf347b7ea	2024-10-11	Warnings	Exact identifier application number: M018
Capasil Pain Relieving	MENTHOL, METHYL SALICYLATE	PureTek Corporation	b1a8e78c-57f0-1f3e-e053-2995a90acbd5	2024-10-01	Warnings	Exact identifier application number: M018
Mencylate Pain Relieving	MENTHOL, METHYL SALICYLATE	PureTek Corporation	f824de86-9492-2e6b-e053-6294a90a6f2a	2024-10-01	Warnings	Exact identifier application number: M018
Advanced Eye Relief/ Redness Maximum Relief	NAPHAZOLINE HYDROCHLORIDE AND HYPROMELLOSE	Bausch & Lomb Incorporated	3c11285a-7e86-4b47-b1ee-e7d59858087d	2024-09-25	Warnings	Exact identifier application number: M018
Muro 128	SODIUM CHLORIDE	Bausch & Lomb Incorporated	cc3d5bc8-9d3c-4c65-9e43-707a2db4081a	2024-09-25	Warnings	Exact identifier application number: M018
Muro 128	SODIUM CHLORIDE	Bausch & Lomb Incorporated	93fafa27-5031-4d95-b4b8-5574b7204ae2	2024-09-25	Warnings	Exact identifier application number: M018
Muro 128	SODIUM CHLORIDE	Bausch & Lomb Incorporated	454f337e-d897-46de-ab05-1c543a33061c	2024-09-25	Warnings	Exact identifier application number: M018
PURPOSE	OCTINOXATE, OCTISALATE AND OXYBENZONE	Bausch & Lomb Incorporated	a1e14135-b8da-4cee-8c5b-1893572f4de4	2024-09-25	Warnings	Exact identifier application number: M018
Soothe Night Time	WHITE PETROLATUM MINERAL OIL	Bausch & Lomb Incorporated	638d3c3f-9960-43da-956e-0e28c77f533e	2024-09-24	Warnings	Exact identifier application number: M018 ndc (product): 24208-313
blink tears	POLYETHYLENE GLYCOL 400	Bausch & Lomb Incorporated	10fcf407-6eaf-4730-9ed0-9b7715cf5701	2024-09-20	Warnings	Exact identifier application number: M018
Soothe XP Preservative Free	LIGHT MINERAL OIL AND MINERAL OIL	Bausch & Lomb Incorporated	b254d885-6d49-4c95-b6be-cfdad49c85e6	2024-09-20	Warnings	Exact identifier application number: M018
blink gel tears	POLYETHYLENE GLYCOL 400	Bausch & Lomb Incorporated	6f7e06c3-204d-459a-af8f-c46be9ad0e8d	2024-09-20	Warnings	Exact identifier application number: M018
Soothe XP	LIGHT MINERAL OIL AND MINERAL OIL	Bausch & Lomb Incorporated	c0f053da-8d22-433e-a36e-79cf15ad387f	2024-09-20	Warnings	Exact identifier application number: M018
Soothe	GLYCERIN AND PROPYLENE GLYCOL	Bausch & Lomb Incorporated	fef002ea-c4bd-4486-a42e-1bbd9d73d28d	2024-09-20	Warnings	Exact identifier application number: M018
Leader Preservative-Free Ultra Lubricating Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Cardinal Health	2a2aa620-ca63-4698-88fd-fc263b8fa0d1	2024-09-07	Warnings	Exact identifier application number: M018
Eyesaline Emergency Eyewash	PURIFIED WATER	Honeywell Safety Products USA, Inc.	ad42a7e3-84ea-390d-e053-2a95a90a3a32	2024-06-14	Warnings	Exact identifier application number: M018
Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	NuCare Pharmaceuticals,Inc.	9c1c4911-908e-3c3c-e053-2995a90abcfc	2024-06-14	Warnings	Exact identifier application number: M018
Eyes Alive Eye Wash	WATER	RIVIERA PHARMA INC	081079f4-1c06-4054-b771-00fedaa666f6	2024-06-05	Warnings	Exact identifier application number: M018
Eyes Alive Lubricating	CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED	RIVIERA PHARMA INC	b6966691-6884-438c-9f89-5924089226e1	2024-05-31	Warnings	Exact identifier application number: M018
Eye Wash	WATER	M-star (Hubei) Health&Care Products Co., Ltd.	71706039-e250-4f08-9687-71b2928c4e46	2024-04-01	Warnings	Exact identifier application number: M018

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
T5L8T28FGP	MINERAL OIL	8042-47-5	MINERAL OIL
4T6H12BN9U	PETROLATUM	8009-03-8	PETROLATUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
259196	mineral oil 20 % / petrolatum 80 % Ophthalmic Ointment	PSN	638d3c3f-9960-43da-956e-0e28c77f533e	8
1235262	Soothe Night Time 20 % / 80 % Ophthalmic Ointment	PSN	638d3c3f-9960-43da-956e-0e28c77f533e	8
1235262	mineral oil 0.2 MG/MG / petrolatum 0.8 MG/MG Ophthalmic Ointment [Soothe Night Time]	SBD	638d3c3f-9960-43da-956e-0e28c77f533e	8
259196	mineral oil 0.2 MG/MG / petrolatum 0.8 MG/MG Ophthalmic Ointment	SCD	638d3c3f-9960-43da-956e-0e28c77f533e	8
1235262	Bausch & Lomb Soothe Night Time (mineral oil 20 % / petrolatum, white 80 % ) Ophthalmic Ointment	SY	638d3c3f-9960-43da-956e-0e28c77f533e	8
259196	mineral oil 20 % / petrolatum 80 % Ophthalmic Ointment	SY	638d3c3f-9960-43da-956e-0e28c77f533e	8
1235262	Soothe Night Time (mineral oil 20 % / petrolatum, white 80 % ) Ophthalmic Ointment	SY	638d3c3f-9960-43da-956e-0e28c77f533e	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
24208-313-34	24208031334	3.5 g in 1 TUBE (24208-313-34)	3.5 g	2011-11-15	0000-00-00	No	No	Current