Ammonium Lactate

Product NDC: 63044-484
11-digit product format: 630440484
Labeler code: 63044
Product ID: 63044-484_cba000ad-31e5-43a5-a992-8ae86298ad6d
Type: HUMAN OTC DRUG
Nonproprietary name: Ammonium Lactate
Dosage form: LOTION
Route: TOPICAL
Labeler: Nnodum Pharmaceuticals
Application: part334
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2007-12-30
Marketing end: 0000-00-00
Substance: AMMONIUM LACTATE
Active strength: 17 g/g
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63044-484		I	Inactivated by FDA		2026-08-17
excluded package	package	63044-484	63044-484-09	I	Inactivated by FDA		2026-08-17

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63044-484-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63044-484-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63044-484-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63044-484-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63044-484-09	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63044-484-09	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63044-484-09	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63044-484-09	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63044-484-09	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63044-484-09	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63044-484-09	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63044-484-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	63044-484-09	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	63044-484-09	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	63044-484-09	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	63044-484-09	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	63044-484-09	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	63044-484-09	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	63044-484-09	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	63044-484-09	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63044-484-09	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	63044-484-09	`110d247fa046…`	`a55b01930146…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63044-484-09	2019-10-21	C162847	48780-1	956f9ecf-c1fe-621f-e053-dbdaa90a74ad	Ammonium Lactate Lotion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63044-484-09	Ammonium Lactate	225 g in 1 BOTTLE, PLASTIC	LOTION	225		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63044-484-09	GM - Gram	63044-484	13c5ec7d-274c-4976-b63d-ada0dc6aaab3	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMMONIUM LACTATE	ACTIVE INGREDIENT	67M901L9NQ	AMMONIUM LACTATE LOTION [NNODUM PHARMACEUTICALS]	1
LACTIC ACID	ACTIVE MOIETY	33X04XA5AT	AMMONIUM LACTATE LOTION [NNODUM PHARMACEUTICALS]	1
CARBOMER HOMOPOLYMER TYPE C	INACTIVE INGREDIENT	4Q93RCW27E	AMMONIUM LACTATE LOTION [NNODUM PHARMACEUTICALS]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	AMMONIUM LACTATE LOTION [NNODUM PHARMACEUTICALS]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	AMMONIUM LACTATE LOTION [NNODUM PHARMACEUTICALS]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	AMMONIUM LACTATE LOTION [NNODUM PHARMACEUTICALS]	1
LIGHT MINERAL OIL	INACTIVE INGREDIENT	N6K5787QVP	AMMONIUM LACTATE LOTION [NNODUM PHARMACEUTICALS]	1
MAGNESIUM ALUMINUM SILICATE	INACTIVE INGREDIENT	6M3P64V0NC	AMMONIUM LACTATE LOTION [NNODUM PHARMACEUTICALS]	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	AMMONIUM LACTATE LOTION [NNODUM PHARMACEUTICALS]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	AMMONIUM LACTATE LOTION [NNODUM PHARMACEUTICALS]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	AMMONIUM LACTATE LOTION [NNODUM PHARMACEUTICALS]	1
PROPYLENE OXIDE	INACTIVE INGREDIENT	Y4Y7NYD4BK	AMMONIUM LACTATE LOTION [NNODUM PHARMACEUTICALS]	1
SODIUM PYRROLIDONE CARBOXYLATE	INACTIVE INGREDIENT	469OTG57A2	AMMONIUM LACTATE LOTION [NNODUM PHARMACEUTICALS]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	AMMONIUM LACTATE LOTION [NNODUM PHARMACEUTICALS]	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	AMMONIUM LACTATE LOTION [NNODUM PHARMACEUTICALS]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	AMMONIUM LACTATE LOTION [NNODUM PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63044-484	AMMONIUM LACTATE LOTION [NNODUM PHARMACEUTICALS]	1	Legacy NDC, 1 package rows	20100101_c81529fe-95b6-4b11-bfc8-cc5f9b8952d3.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
67M901L9NQ	AMMONIUM LACTATE	515-98-0	AMMONIUM LACTATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197362	ammonium lactate 12 % Topical Lotion	PSN	c81529fe-95b6-4b11-bfc8-cc5f9b8952d3	1
197362	ammonium lactate 120 MG/ML Topical Lotion	SCD	c81529fe-95b6-4b11-bfc8-cc5f9b8952d3	1
197362	ammonium lactate 12 % Topical Lotion	SY	c81529fe-95b6-4b11-bfc8-cc5f9b8952d3	1
197362	ammonium lactate 120 MG/ML (as neutralized lactic acid 12 % ) Topical Lotion	SY	c81529fe-95b6-4b11-bfc8-cc5f9b8952d3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
63044-484-09	63044048409	225 g in 1 BOTTLE, PLASTIC	225 g	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ammonium Lactate Lotion	Nnodum Pharmaceuticals \| Alliance Packaging Group	2009-12-29	HUMAN OTC DRUG LABEL	1